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 |
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 |
|
|