FDA 510(k) Applications for Medical Device:
Bone Grafting Material, Synthetic
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K051381 | ACE SURGICAL SUPPLY CO., INC. |
1034 PEARL ST. | BROCKTON | MA | 02301 |
| K090850 | APATECH LTD. |
15058 ARMEL DRIVE | OREGON CITY | OR | 97045 |
| K994137 | ATRIX LABORATORIES, INC. |
2579 MIDPOINT DR. | FORT COLLINS | CO | 80525-4417 |
| K121177 | AUGMA BIOMATERIALS, LTD. |
11234 EL CAMINO REAL | SAN DIEGO | CA | 92130 |
| K083858 | AUGMA BIOMATERIALS, LTD. |
11234 EL CAMINO REAL | SAN DIEGO | CA | 92130 |
| K081721 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K073571 | BAXTER HEALTHCARE CORPORATION |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K051091 | BICON, INC. |
501 ARBORWAY | BOSTON | MA | 02130 |
| K954763 | BIO-INTERFACES, INC. |
11095 FLINTKOTE AVE. | SAN DIEGO | CA | 92121 |
| K960164 | BIO-INTERFACES, INC. |
11095 FLINTKOTE AVE. | SAN DIEGO | CA | 92121 |
| K060285 | BIO-LOK INTL., INC. |
505 MORRIS AVENUE, SUITE 104 | SPRINGFIELD | NJ | 07081 |
| K090793 | BIOALPHA, INC. |
223-23 SANGDAEWON-DONG | SEONGNAM, GYEONGGI-DO | 462-120 | |
| K960267 | BIOCOLL LABORATORIES, INC. |
1247 FLORIDA AVE. | PALM HARBOR | FL | 34683 |
| K082383 | BIOCOMPOSITES LTD. |
KEELE SCIENCE PARK | KEELE, STAFFORDSHIRE | ST5 5NL | |
| K050170 | BIOCOMPOSITES LTD. |
KEELE SCIENCE PARK | KEELE, STAFFORDSHIRE | ST5 5NL | |
| K993238 | BIOCOMPOSITES LTD. |
ETRUSCAN ST., ETRURIA | STOKE ON TRENT | ST1 5PQ | |
| K030682 | BIOFORM, INC. |
4133 COURTNEY ROAD, #10 | FRANKSVILLE | WI | 53126 |
| K051885 | BIOMATLANTE |
5, RUE EDOUARD BELIN | VIGNEUX DE BRETAGNE | 44360 | |
| K060732 | BIOMATLANTE |
5, RUE EDOUARD BELIN | VIGNEUX DE BRETAGNE | 44360 | |
| K093122 | BIOMATLANTE |
5, RUE EDOUARD BELIN | VIGNEUX DE BRETAGNE | 44360 | |
| K110449 | BIOMET 3I |
4555 RIVERSIDE DRIVE | PALM BEACH GARDENS | FL | 33410 |
| K003493 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K980679 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K003494 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K080308 | BIOSCAFFOLD INTERNATIONAL PTE LTD |
PIAZZA ALBANIA, 10 | ROME | 00153 | |
| K000633 | BLUE SKY BIO |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K110198 | BLUE SKY BIO, LLC |
888 E BELVIDERE RD. | GRAYSLAKE | IL | 60030 |
| K083372 | BRAINBASE CORPORATION |
26420 SUMMER GREENS DR. | BONITA SPRINGS | FL | 34135 |
| K962786 | CERAMED CORP. |
12860 WEST CEDAR DR., STE. 110 | LAKEWOOD | CO | 80228 |
| K960353 | CERAMED CORP. |
12860 WEST CEDAR DR., STE. 110 | LAKEWOOD | CO | 80228 |
| K960348 | CERAMED CORP. |
12860 WEST CEDAR DR., STE. 110 | LAKEWOOD | CO | 80228 |
| K954631 | CERAMED CORP. |
12860 WEST CEDAR DRIVE, | LAKEWOOD | CO | 80228 |
| K960368 | CERAMED CORP. |
12860 WEST CEDAR DR., STE. 110 | LAKEWOOD | CO | 80228 |
| K960361 | CERAMED CORP. |
12860 WEST CEDAR DR., STE. 110 | LAKEWOOD | CO | 80228 |
| K962838 | CERAMED CORP. |
12860 WEST CEDAR DR., STE. 110 | LAKEWOOD | CO | 80228 |
| K981182 | CERAMED DENTAL, LLC. |
12860 WEST CEDAR DR., | LAKEWOOD | CO | 80228 |
| K981214 | CERAMED DENTAL, LLC. |
12860 WEST CEDAR DR., | LAKEWOOD | CO | 80228 |
| K103820 | CERAMISYS LTD |
344 ANNABELLE POINT ROAD | CENTERVILLE | MA | 02632-2402 |
| K001598 | COL-BAR LTD. |
555 13TH STREET, N.W. | WASHINGTON | DC | 20004 |
| K033729 | COLLAGEN MATRIX, INC. |
509 COMMERCE ST. | FRANKLIN LAKES, | NJ | 07417 |
| K083742 | COLLAGEN MATRIX, INC. |
509 COMMERCE ST. | FRANKLIN LAKES | NJ | 07417 |
| K072397 | COLLAGEN MATRIX, INC. |
509 COMMERCE ST. | FRANKLIN LAKES | NJ | 07417 |
| K103709 | CURASAN AG |
PIAZZA ALBANIA, 10 | ROME | 00153 | |
| K111105 | CURASAN AG |
PIAZZA ALBANIA 10 | ROME | 00153 | |
| K102872 | CURASAN AG |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K051443 | CURASAN AG, FRANKFURT FACILITY |
109 SHORE DRIVE | GARNER | NC | 27529 |
| K093871 | CYTOPHIL INC |
2485 CORPORATE CIRCLE | EAST TROY | WI | 53120 |
| K092788 | CYTOPHIL INC |
2485 CORPORATE CIRCLE | EAST TROY | WI | 53120 |
| K131385 | Degradable Solutions AG |
901 KING STREET | ALEXANDRIA | VA | 22314 |
| K072052 | DENTSPLY INTERNATIONAL, INC. |
1311 SMILE WAY | YORK | PA | 17404 |
| K072056 | DENTSPLY INTERNATIONAL, INC. |
1311 SMILE WAY | YORK | PA | 17404 |
| K072057 | DENTSPLY INTERNATIONAL, INC. |
SUSQUEHANNA COMMERCE CTR., 221 | YORK | PA | 17404 |
| K072058 | DENTSPLY INTERNTIONAL |
221 W. PHILADELPHIA ST. STE.60 | YORK | PA | 17404 |
| K071817 | DENTSPLY INTERNTIONAL |
221 W. PHILADELPHIA ST. STE.60 | YORK | PA | 17404 |
| K010320 | DEPUY ACROMED |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K003286 | DEPUY ACROMED |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K093390 | DEPUY SPINE, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K081432 | DEPUY SPINE, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K213260 | Dimension Inx Corp. |
3440 S Dearborn St. Suite 142S | Chicago | IL | 60616 |
| K091729 | ETEX CORP. |
38 SIDNEY ST., 3FLR | CAMBRIDGE | MA | 02139 |
| K962548 | ETEX CORP. |
38 SIDNEY ST., 3FLR | CAMBRIDGE | MA | 02139 |
| K100883 | ETEX CORP. |
38 SIDNEY ST. | CAMBRIDGE | MA | 02139 |
| K102812 | ETEX CORPORATION |
38 SIDNEY STREET | CAMBRIDGE | MA | 02139 |
| K023799 | FRIADENT GMBH |
21911 ERIE LN. | LAKE FOREST | CA | 92630 |
| K192597 | GC America, Inc. |
3737 W. 127th St. | Alsip | IL | 60803 |
| K970569 | GEISTLICH-PHARMA |
1050 CONNECTICUT AVE. N.W. | WASHINGTON | DC | 20036 |
| K970321 | GEISTLICH-PHARMA |
1050 CONNECTICUT AVE. N.W. | WASHINGTON | DC | 20036 |
| K974399 | GEISTLICH-PHARMA |
WASHINGTON SQUARE | WASHINGTON | DC | 20036 |
| K014289 | GEISTLICH-PHARMA |
1050 CONNECTICUT AVE. N.W. | WASHINGTON | DC | 20036 |
| K972817 | GEISTLICH-PHARMA |
1050 CONNECTICUT AVE. N.W. | WASHINGTON | DC | 20036 |
| K112716 | GENOSS CO., LTD. |
1F GYEONGGI R&D CENTER | SUWON-SI YEONGTONG-GU, GYEONGG | 443-270 | |
| K153676 | GENOSS CO., LTD. |
1F GYEONGGI R&DB CENTER, 105 GWANGGYO-RO, | SUWON-SI | 433-270 | |
| K062834 | GENOSS CO., LTD. |
28711 JAEGER DRIVE | LAGUNA NIGUEL | CA | 92677 |
| K102015 | GENOSS CO., LTD. |
11075 KNOTT AVE., SUITE A | CYPRESS | CA | 90630 |
| K082286 | GRAFTYS |
415 RUE CHARLES NICOLAS LEDOUX | AIX EN PROVENCE | 13854 | |
| K011032 | HARVEST TECHNOLOGIES, CORP. |
40 GRISSOM RD. | PLYMOUTH | MA | 02360 |
| K030052 | HERAEUS KULZER, INC. |
4315 SOUTH LAFAYETTE BLVD. | SOUTH BEND | IN | 46614-2517 |
| K033098 | IMPLADENT, LTD. |
198-45 FOOTHILL AVE. | HOLLISWOOD | NY | 11423 |
| K012047 | IMPLANT INNOVATIONS, INC. |
56 E BELL DR. | WARSAW | IN | 46582 |
| K010775 | IMTEC CORP. |
2401 NORTH COMMERCE | ARDMORE | OK | 73401 |
| K020396 | IMTEC CORP. |
2401 NORTH COMMERCE | ARDMORE | OK | 73401 |
| K950306 | IMTEC CORP. |
2007 N. COMMERCE | ARDMORE | OK | 73402 |
| K070784 | INION OY |
LAAKARINKATU 2 | TAMPERE | 33520 | |
| K201051 | Institut Straumann AG |
Peter Merian-Weg 12 | Basel | CH-4002 | |
| K992216 | INTEGRA LIFESCIENCES CORP. |
105 MORGAN LN. | PLAINSBORO | NJ | 08536 |
| K972842 | INTERPORE INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K031813 | ISOTIS NV |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K042706 | ISOTIS ORTHOBIOLOGICS, INC |
2 GOODYEAR, SUITE B | IRVINE | CA | 92618 |
| K050984 | KERR DENTAL MATERIALS CENTER |
1717 WEST COLLINS AVE. | ORANGE | CA | 92867 |
| K092194 | KYUNGWON MEDICAL CO., LTD. |
13340 EAST FIRESTONE BLVD. | SANTA FE SPRINGS | CA | 90670 |
| K042730 | LIFECORE BIOMEDICAL |
3515 LYMAN BLVD. | CHASKA | MN | 55318 |
| K041324 | LIFECORE BIOMEDICAL, INC. |
3515 LYMAN BLVD. | CHASKA | MN | 55318 |
| K955096 | LIFECORE BIOMEDICAL, INC. |
3515 LYMAN BLVD. | CHASKA | MN | 55318 |
| K990537 | LUITPOLD PHARMACEUTICALS, INC. |
1050 CONNECTICUT AVENUE, N.W. | WASHINGTON | DC | 20036-5339 |
| K101014 | M.I.S. IMPLANTS TECHNOLOGIES LTD. |
P.O. BOX 7 | BAR LEV INDUSTRIAL PARK | 20156 | |
| K101426 | MATHYS LTD |
11234 EL CAMINO REAL | SAN DIEGO | CA | 92130-8587 |
| K081784 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K082917 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132-3576 |
| K140374 | MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K092087 | MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K010701 | MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K090950 | MEGAGEN IMPLANT CO., LTD |
13340 E. FIRESTONE BLVD. | SANTA FE SPRINGS | CA | 90670 |
| K122240 | MEGAGEN IMPLANT CO., LTD |
325 N PUENTE ST. UNIT B | BREA | CA | 92821 |
| K080772 | META BIOMED CO., LTD. |
414-21 MO CHOONG DONG, | REPUBLIC OF KOREA | ||
| K983104 | NORIAN CORP. |
10260 BUBB RD. | CUPERTINO | CA | 95014-4166 |
| K112428 | NovaBone Products, LLC |
13631 PROGRESS BLVD | ALACHUA | FL | 32615 |
| K091484 | NovaBone Products, LLC |
13709 PROGRESS BLVD., #33 | ALACHUA | FL | 32615 |
| K100671 | NovaBone Products, LLC |
13631 PROGRESS BLVD | ALACHUA | FL | 32615 |
| K063549 | NovaBone Products, LLC |
ONE PROGRESS BLVD. | ALACHUA | FL | 32615 |
| K033994 | NovaBone Products, LLC |
ONE PROGRESS BLVD. | ALACHUA | FL | 32615 |
| K053387 | NovaBone Products, LLC |
13709 PROGRESS BLVD., #33 | ALACHUA | FL | 32615 |
| K031073 | NovaBone Products, LLC |
ONE PROGRESS BLVD. | ALACHUA | FL | 32615 |
| K063596 | NovaBone Products, LLC |
13709 PROGRESS BLVD., #33 | ALACHUA | FL | 32615 |
| K040278 | NovaBone Products, LLC |
13709 PROGRESS BLVD., #33 | ALACHUA | FL | 32615 |
| K030195 | OCT, USA, INC. |
13 RED FOX LN. | LITTLETON | CO | 80127 |
| K111087 | OLYMPUS TERUMO BIOMATERIALS CORPORATION |
5600 WISONSIN AVENUE, | CHEVY CHASE | MD | 20815 |
| K081561 | OLYMPUS TERUMO BIOMATERIALS CORPORATION |
3500 CORPORATE PARKWAY | CENTER VALLEY | PA | 18034-0610 |
| K050260 | ORALTRONICS DENTAL IMPLANT TECHNOLOGY GMBH |
3234 64TH ST. | LUBBOCK | TX | 79413 |
| K011403 | ORTHOGEN CORP. |
P.O. BOX 560 | STILLWATER | MN | 55082 |
| K102208 | ORTHOGEN, LLC |
505 MORRIS AVENUE, | SPRINGFIELD | NJ | 07081 |
| K091618 | ORTHOVITA, INC. |
45 GREAT VALLEY PKWY. | MALVERN | PA | 19355 |
| K053374 | OSSACUR AG |
975 VERONICS SPRINGS ROAD | SANTA BARBARA | CA | 93105 |
| K202675 | Osteogene Tech Corp |
75 Oak Street | Norwood | NJ | 07648 |
| K993610 | OSTEOGENICS BIOMEDICAL, INC. |
6401 MEADOWS WEST DR. | FORT WORTH | TX | 76132 |
| K964342 | OSTEOGENICS CO. |
100 EAST 15TH STREET,SUITE 320 | FORTH WORTH | TX | 76102 |
| K972278 | OSTEOGENICS CO. |
6401 MEADOWS WEST DR. | FORT WORTH | TX | 76132 |
| K201546 | RevisiOs BV |
Professor Bronkhorstlaan 10, Building 48 | 3723 MB Bilthoven | ||
| K113282 | RIEMSER ARZEIMITTEL AG |
5105 FAIROAKS RD | DURHAM | NC | 27712 |
| K063634 | SEPTODONT |
1050 CONNECTICUT AVE., NW | WASHINGTON | DC | 20036 |
| K241186 | Shenzhen Dazhou Medical Technology Co., Ltd. |
St B605, Bldg No.1, Yesun Intelligent Community II, 1301-76 | Shenzhen | 518110 | |
| K063010 | STEINER LABORATORIES |
590 FARRINGTON HWY. | KAPOLEI | HI | 96707 |
| K052493 | STEINER LABORATORIES |
590 FARRINGTON HWY. | KAPOLEI | HI | 96707 |
| K113049 | STEINER LABORATORIES |
590 FARRINGTON HWY. | KAPOLEI | HI | 96707 |
| K101718 | STEINER LABORATORIES DIV OF STEINER HEALTHCARE LLC |
590 FARRINGTON HWY., #524 | KAPOLEI | HI | 96707 |
| K053022 | SYNTHES (USA) |
1302 WRIGHTS LANE EAST | WEST CHESTER | PA | 19380 |
| K083005 | TEKNIMED SA |
1001 OAKWOOD BLVD | ROUNDROCK | TX | 78681 |
| K062102 | TEKNIMED SA |
1001 OAKWOOD BLVD | ROUNDROCK | TX | 78681 |
| K040783 | TERUMO CORP. |
1425 K STREET N.W. | WASHINGTON | DC | 20005 |
| K101827 | TEXAS INNOVATIVE MEDICAL DEVICES (DBA) SKELETAL |
4808 RESEARCH DRIVE | SAN ANTONIO | TX | 78240 |
| K033110 | THE CLINICIAN'S PREFERENCE LLC |
388 MARKET STREET, SUITE 500 | SAN FRANCISCO | CA | 94111 |
| K153230 | THE IMPLANTECH INC./SHEFABONE |
9016 CLIFF CAMERON DR., #201 | CHARLOTTE | NC | 28269 |
| K040646 | THE STRAUMANN CO. |
RESERVOIR PL. 1601 TRAPELO RD. | WALTHAM | MA | 02451 |
| K023998 | THERICS, INC. |
115 CAMPUS DR. | PRINCETON | NJ | 08540 |
| K940643 | THM BIOMEDICAL, INC. |
325 LAKE AVE. S. STE. #608 | DULUTH | MN | 55802 |
| K000149 | U.S. BIOMATERIALS CORP. |
ONE PROGRESS BLVD. | ALACHUA | FL | 32615 |
| K962494 | U.S. BIOMATERIALS CORP. |
ONE PROGRESS BLVD. | ALACHUA | FL | 32615 |
| K992416 | U.S. BIOMATERIALS CORP. |
ONE PROGRESS BLVD. | ALACHUA | FL | 32615 |
| K042583 | ULTRADENT PRODUCTS, INC. |
505 WEST 10200 SOUTH | SOUTH JORDAN | UT | 84095 |
| K982699 | UNICARE BIOMEDICAL |
25951 LA CUESTA AVE. | LAGUNA HILLS | CA | 92653 |
| K003457 | UNICARE BIOMEDICAL |
25951 LA CUESTA AVE. | LAGUNA HILLS | CA | 92653 |
| K993784 | UNICARE BIOMEDICAL |
25951 LA CUESTA AVE. | LAGUNA HILLS | CA | 92653 |
| K012144 | UNICARE BIOMEDICAL, INC. |
25951 LA CUESTA AVE. | LAGUNA HILLS | CA | 92653 |
| K090083 | UNICARE BIOMEDICAL, INC. |
22971-B TRITON WAY | LAGUNA HILLS | CA | 92653 |
| K092567 | UNICARE BIOMEDICAL, INC. |
22971-B TRITON WAY | LAGUNA HILLS | CA | 92653 |
| K020720 | UNICARE BIOMEDICAL, INC. |
25951 LA CUESTA AVE. | LAGUNA HILLS | CA | 92653 |
| K070055 | VIVOXID LTD. |
6470 RIVERVIEW TERRACE | FRIDLEY | MN | 55432 |
| K013346 | W.L. GORE & ASSOCIATES,INC |
3450 KILTIE LN. | FLAGSTAFF | AZ | 86002-0500 |
| K973594 | W.L. GORE & ASSOCIATES,INC |
301 AIRPORT RD | ELKTON | MD | 21922-1408 |
| K962624 | W.L. GORE & ASSOCIATES,INC |
1500 NORTH FOURTH ST. | FLAGSTAFF | AZ | 86004 |
| K970884 | W.L. GORE & ASSOCIATES,INC |
1500 NORTH FOURTH ST. | FLAGSTAFF | AZ | 86004 |
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