FDA 510(k) Applications for Medical Device:
External Mandibular Fixator And/Or Distractor
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K952847 | ACE SURGICAL SUPPLY CO., INC. |
1034 PEARL ST. | BROCKTON | MA | 02403 |
| K955640 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K062572 | CUSTOM SCIENTIFIC |
5600 WISCONSIN AVE, # 509 | CHEVY CHASE | MD | 20815 |
| K960297 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K984117 | INNOVA CORP. |
C/O HOGAN & HARTSON | WASHINGTON | DC | 20004 |
| K993869 | INTER-OS TECHNOLOGIES, L.L.C. |
7144 S. CHAPPARAL CIR. E. | AURORA | CO | 80016 |
| K080542 | JOHN W. KING |
800 EAST LEIGH STREET | RICHMOND | VA | 23219 |
| K220050 | KLS Martin L.P. |
11201 Saint Johns Industrial Parkway S | Jacksonville | FL | 32246 |
| K072764 | KLS MARTIN L.P. |
11239 ST. JOHNS INDUSTRIAL | JACKSONVILLE | FL | 32246 |
| K161470 | KLS MARTIN LP |
11201 SAINT JOHNS INDUSTRIAL PKWY S | JACKSONVILLE | FL | 32246 |
| K991875 | KLS-MARTIN L.P. |
3234 ELLA LN. | NEW PORT RICHEY | FL | 34655 |
| K983515 | KLS-MARTIN L.P. |
3234 ELLA LN. | NEW PORT RICHEY | FL | 34655 |
| K034027 | KLS-MARTIN L.P. |
11239-1 ST. JOHN'S IND. PKWY. | JACKSONVILLE | FL | 32246 |
| K983809 | KLS-MARTIN L.P. |
3234 ELLA LN. | NEW PORT RICHEY | FL | 34655 |
| K973275 | KLS-MARTIN L.P. |
3234 ELLA LN. | NEW PORT RICHEY | FL | 34655 |
| K032442 | KLS-MARTIN L.P. |
11239-1 ST. JOHN'S IND. PKWY. | JACKSONVILLE | FL | 32246 |
| K972047 | KLS-MARTIN L.P. |
40178 U.S. 19 NORTH | TARPON SPRINGS | FL | 34689 |
| K002152 | KLS-MARTIN L.P. |
3234 ELLA LN. | NEW PORT RICHEY | FL | 34655 |
| K010139 | KLS-MARTIN L.P. |
3234 ELLA LN. | NEW PORT RICHEY | FL | 34655 |
| K000580 | KLS-MARTIN L.P. |
3234 ELLA LN. | NEW PORT RICHEY | FL | 34655 |
| K000992 | MACROPORE BIOSURGERY, INC. |
6740 TOP GUN ST. | SAN DIEGO | CA | 92121 |
| K051946 | MEDARTIS, INC. |
11234 EL CAMINO REAL, STE 200 | SAN DIEGO | CA | 92130 |
| K080458 | MIS - IMPLANT TECHNOLOGIES LTD. |
POB 110 | SHLOMI | 22832 | |
| K030485 | NEWMEDICAL TECHNOLOGY, INC. |
N.14 W.23833 STONE RIDGE DR. | WAUKESHA | WI | 53188 |
| K014001 | ORAL OSTEODISTRACTION, L.P. |
962 ALLEGRO LN. | APOLLO BEACH | FL | 33572 |
| K034045 | ORAL OSTEODISTRACTION, L.P. |
962 ALLEGRO LANE | APOLLO BEACH | FL | 33572 |
| K042278 | ORAL OSTEODISTRACTION, L.P. |
962 ALLEGRO LN. | APOLLO BEACH | FL | 33572 |
| K013618 | OSTEOMED CORP. |
3750 REALTY RD. | ADDISON | TX | 75001-4311 |
| K990944 | OSTEOMED CORP. |
3750 REALTY RD. | ADDISON | TX | 75001-4311 |
| K030790 | OSTEOMED L.P. |
3885 ARAPAHO RD. | ADDISON | TX | 75001 |
| K063792 | OSTEOMED L.P. |
3885 ARAPAHO RD. | ADDISON | TX | 75001 |
| K031708 | OSTEOMED L.P. |
3885 ARAPAHO RD. | ADDISON | TX | 75001 |
| K043434 | OSTEOMED L.P. |
3885 ARAPAHO RD. | ADDISON | TX | 75001 |
| K062851 | OSTEOMED L.P. |
3885 ARAPAHO RD. | ADDISON | TX | 75001 |
| K133398 | Stryker |
750 TRADE CENTRE WAY | PORTAGE | MI | 49002 |
| K181504 | Stryker |
750 Trade Centre Way - Suite 200 | Portage | MI | 49002 |
| K071628 | STRYKER CMF |
750 TRADE CENTRE WAY | KALAMAZOO | MI | 49001 |
| K981075 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K060138 | SYNTHES (USA) |
1301 GOSHEN PKWY. | WEST CHESTER | PA | 19380 |
| K080153 | SYNTHES (USA) |
1301 GOSHEN PKWY | WEST CHESTER | PA | 19380 |
| K981275 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K033065 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K043555 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K040083 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K962272 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K040169 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K050378 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K973018 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K062299 | SYNTHES (USA) |
1301 GOSHEN PKWY | WEST CHESTER | PA | 19380 |
| K183113 | Synthes (USA) Products LLC |
1301 Goshen Parkway | West Chester | PA | 19380 |
| K121502 | SYNTHES INC |
1301 Goshen Parkway | West Chester | PA | 19380 |
| K162594 | SYNTHES USA PRODUCTS, LLC |
1301 GOSHEN PARKWAY | WEST CHESTER | PA | 19380 |
| K143285 | Synthes USA Products, LLC |
1302 Wrights Lane | West Chester | PA | 19380 |
| K020407 | WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. | JACKSONVILLE | FL | 32218 |
| K992952 | WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. | JACKSONVILLE | FL | 32218 |
| K992873 | WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. | JACKSONVILLE | FL | 32218 |
| K982906 | WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. | JACKSONVILLE | FL | 32218 |
| K982604 | WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. | JACKSONVILLE | FL | 32218 |
| K031696 | WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. | JACKSONVILLE | FL | 32218 |
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