FDA 510(k) Applications for Medical Device:
Pin, Fixation, Threaded
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K131459 | AAP IMPLANTATE AG |
LORENZWEG 5 | BERLIN | 12099 | |
| K083144 | ACUMED LLC |
5885 NW CORNELIUS PASS RD. | HILLSBORO | OR | 97124 |
| K980788 | ALPHATEC MFG., INC. |
42-160 STATE ST. | PALM DESERT | CA | 92211-5148 |
| K981716 | AVANTA ORTHOPAEDICS, INC. |
9369 CARROLL PARK DRIVE, STE.A | SAN DIEGO | CA | 92121 |
| K974911 | AVANTA ORTHOPAEDICS, INC. |
9369 CARROLL PARK DRIVE, STE.A | SAN DIEGO | CA | 92121 |
| K241357 | Biodynamik, Inc. |
11 Orchard Road | Lake Forest | CA | 92630 |
| K003294 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K003131 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K021182 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K011137 | BIOMET, INC. |
P.O. BOX 587 | WARSAW | IN | 46581-0587 |
| K130298 | BIOPRO, INC. |
3150 E. 200TH ST | PRIOR LAKE | MN | 55372 |
| K061599 | BK MEDITECH CO., LTD. |
215-5 YODANG-LI, YANGGAM-MYUN | HWASUNG-SI, KYUNGGI-DO | ||
| K990353 | BREGMA INTERNATIONAL TRADING COMPANY LTD. |
214-111 RESEARCH DR. | SASKATOON, SASKATCHEWAN | S7N 3R2 | |
| K150661 | CITIEFFE s.r.l |
Via Armaroli 21 | Calderara di Reno | 400012 | |
| K103001 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K963973 | DEPUY, INC. |
700 ORTHOPAEDIC DR. | WARSAW | IN | 46581-0988 |
| K991649 | DEPUY, INC. |
700 ORTHOPAEDIC DR. | WARSAW | IN | 46581-0988 |
| K192768 | EiserTech, LLC |
9988 Hibert Street Suite 302 | San Diego | CA | 32131 |
| K140875 | GENOSSIS, LLC |
29 WATER STREET, SUITE 305 | NEWBURYPORT | MA | 01950 |
| K992970 | HAND BIOMECHANICS LAB, INC. |
77 SCRIPPS DR., SUITE 104 | SACRAMENTO | CA | 95825 |
| K982068 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K001886 | HOWMEDICA OSTEONICS CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070-2584 |
| K011136 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K001228 | IMMEDICA, INC. |
100 PASSAIC AVE. | CHATHAM | NJ | 07928-2848 |
| K961920 | MEDICINE LODGE, INC. |
152 SOUTH 600 WEST | LOGAN | UT | 84321 |
| K100414 | MERETE MEDICAL GMBH |
ALT LANKWITZ 102 | BERLIN | 12247 | |
| K102777 | MERETE MEDICAL GMBH |
102 ALT LANKWITZ | BERLIN | D-12247 | |
| K061498 | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
125 MAY STREET | EDISON | NJ | 08837 |
| K011875 | NEWDEAL S.A. |
9109 COPENHAVER DR. | POTOMAC | MD | 20854 |
| K993910 | NEWDEAL S.A. |
9109 COPENHAVER DR. | POTOMAC | MD | 20854 |
| K072710 | NEXA ORTHOPEDICS, INC. |
11035 ROSELLE STREET | SAN DIEGO | CA | 92121 |
| K051740 | NEXA ORTHOPEDICS, INC. |
990 PARK CENTER DR., SUITE H | VISTA | CA | 92081 |
| K974186 | ORTHOFIX SRL |
12300 TWINBROOK PARKWAY, | ROCKVILLE | MD | 20852 |
| K955848 | ORTHOFIX, INC. |
12300 TWINBROOK PKWY. | ROCKVILLE | MD | 20852 |
| K963433 | ORTHOPAEDIC BIOSYSTEMS, LTD. |
7320 EAST BUTHERUS | SCOTSDALE | AZ | 85260 |
| K964893 | OSTEONICS CORP. |
59 ROUTE 17 | ALLENDALE | NJ | 07401-1677 |
| K960023 | PROMEX, INC. |
1125 BROOKSIDE AVE. | INDIANAPOLIS | IN | 46202 |
| K982931 | SGARLATO LABORATORIES, INC. |
250 ALMENDRA AVE. | LOS GATOS | CA | 95030 |
| K031154 | SINTEA BIOTECH, INC. |
407 LINCOLN RD. SUITE 10L | MIAMI BEACH | FL | 33139 |
| K071540 | SMALL BONE INNOVATIONS INC. |
505 PARK AVE., 14TH FLOOR | NEW YORK | NY | 10022 |
| K210784 | Smith & Nephew, Inc. |
1450 E Brooks Rd | Memphis | TN | 38116 |
| K023921 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K023134 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K213874 | Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K223112 | Smith & Nephew, Inc. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K033289 | SMITH & NEPHEW, INC. |
7135 Goodlett Farms Parkway | Cordova | TN | 38016 |
| K994143 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K120871 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K970713 | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K970751 | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K012270 | Stryker Endoscopy |
2590 WALSH AVE. | SANTA CLARA | CA | 95051-4085 |
| K020097 | Stryker Endoscopy |
2590 WALSH AVE. | SANTA CLARA | CA | 95051-4085 |
| K011319 | Stryker Endoscopy |
2590 WALSH AVE. | SANTA CLARA | CA | 95051-4085 |
| K211508 | Stryker GmbH |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K061493 | STRYKER HOWMEDICA OSTEONICS |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K182171 | Summit MedVentures |
7500 Rialto Blvd, Bldg 1, Ste 225 | Austin | TX | 78738 |
| K983757 | SYNTEC SCIENTIFIC CORP. |
2, KUNG SAN ROAD, CHAUN SHING | CHANG HUA | 509 | |
| K200933 | Syntec Scientific Corporation |
No.2, Kung San Road Chuan Shing Industrial Zone, Shen Kang | Chang Hua | 50971 | |
| K002605 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K970097 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K040765 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K001720 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K030336 | TELEFLEX MEDICAL GROUP |
50 PLANTATION DR. | JAFFREY | NH | 03452 |
| K191803 | Tinavi (Anhui) Medical Technologies Co., Ltd. |
Building 5,Robot Industrial Base of TusCity, | Hefei | 230601 | |
| K053513 | UNION SURGICAL LLC |
834 CHESTNUT STREET | PHILADELPHIA | PA | 19107 |
| K032532 | UNION SURGICAL LLC |
834 CHESTNUT STREET | PHILADELPHIA | PA | 19107 |
| K163487 | Vilex in Tennessee, Inc |
111 Moffitt Street | McMinnville | TN | 37110 |
| K132820 | VILEX, INC. |
7214 LAKE FOREST GLEN | LAKEWOOD RANCH | FL | 34202 |
| K955780 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
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