FDA 510(k) Applications for Medical Device:
Washer, Bolt Nut
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K112111 |
ACUMED LLC |
5885 NW CORNELIUS PASS RD.
| HILLSBORO |
OR |
97124-9432 |
K212990 |
Acumed LLC |
5885 NE Cornelius Pass Road
| Hillsboro |
OR |
97124 |
K130986 |
ACUMED LLC |
5885 NW CORNELIUS PASS RD.
| HILLSBORO |
OR |
97124-9432 |
K965028 |
ACUMED, INC. |
10950 S.W. 5TH ST.
| BEAVERTON |
OR |
97005 |
K954148 |
ACUMED, INC. |
10950 S.W. 5TH ST.
| BEAVERTON |
OR |
97005 |
K162805 |
Akros Medical |
3503 Pleasant Green Rd
| Durham |
NC |
27705 |
K173550 |
Akros Medical |
3503 Pleasant Green Rd
| Durham |
NC |
27705 |
K200361 |
Akros Medical |
3503 Pleasant Green Rd
| Durham |
NC |
27705 |
K221485 |
Arthrex Inc. |
1370 Creekside Boulevard
| Naples |
FL |
34108-1945 |
K232755 |
Arthrex Inc. |
1370 Creekside Boulevard
| Naples |
FL |
34108-1945 |
K220947 |
Arthrex Inc. |
1370 Creekside Boulevard
| Naples |
FL |
34108-1945 |
K213644 |
Arthrex Inc. |
1370 Creekside Boulevard
| Naples |
FL |
34108-1945 |
K201522 |
Arthrex Inc. |
1370 Creekside Boulevard
| Naples |
FL |
34108-1945 |
K112437 |
ARTHREX, INC. |
1370 CREEKSIDE BLVD.
| NAPLES |
FL |
34108-1945 |
K023119 |
ARTHREX, INC. |
2885 SOUTH HORSESHOE DR.
| NAPLES |
FL |
34104 |
K043145 |
ARTHREX, INC. |
1370 CREEKSIDE BLVD.
| NAPLES |
FL |
34108-1945 |
K140328 |
ARTHREX, INC. |
1370 CREEKSIDE BLVD.
| NAPLES |
FL |
34108-1945 |
K133275 |
ARTHREX, INC. |
1370 Creekside Blvd
| Naples |
FL |
34108 |
K090107 |
ARTHREX, INC. |
1370 CREEKSIDE BLVD.
| NAPLES |
FL |
34108-1945 |
K071978 |
ARTHREX, INC. |
1370 CREEKSIDE BLVD.
| NAPLES |
FL |
34108-1945 |
K061925 |
ARTHREX, INC. |
1370 CREEKSIDE BLVD.
| NAPLES |
FL |
34108-1945 |
K052776 |
ARTHREX, INC. |
1370 CREEKSIDE BLVD.
| NAPLES |
FL |
34108-1945 |
K043248 |
ARTHREX, INC. |
1370 CREEKSIDE BLVD.
| NAPLES |
FL |
34108-1945 |
K170440 |
Arthrosurface, Inc |
28 Forge Parkway
| Franklin |
MA |
02038 |
K133835 |
ARTHROSURFACE, INC. |
28 FORGE PARKWAY
| FRANKLIN |
MA |
02038 |
K141219 |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE
| WARSAW |
IN |
46581-0587 |
K132510 |
BIOPRO, INC. |
3150 E. 200TH ST
| PRIOR LAKE |
MN |
55372 |
K190516 |
CONMED Corporation |
525 French Road
| Utica |
NY |
13502 |
K190582 |
CONMED Corporation |
525 French Road
| Utica |
NY |
13502 |
K153211 |
CORACOID SOLUTIONS, INC. |
15 NORMANS WAY
| PARK CITY |
UT |
84060 |
K190143 |
Corin USA |
12750 Citrus Park Lane, Suite 120
| Tampa |
FL |
33625 |
K183094 |
Cycla Orthopedics Ltd |
14 Hame Yasdim st.
| Bat shlomo |
|
30992 |
K131850 |
DALLEN MEDICAL, INC. |
1046 Calle Recodo Ste G
| San Clemente |
CA |
92673 |
K133858 |
DALLEN MEDICAL, INC. |
1046 Calle Recodo Ste G
| San Clemente |
CA |
92673 |
K141264 |
DALLEN MEDICAL, INC. |
1046 Calle Recodo Ste G
| San Clemente |
CA |
92673 |
K143092 |
DALLEN MEDICAL, INC. |
1046 Calle Recodo Ste G
| San Clemente |
CA |
92673 |
K150359 |
DALLEN MEDICAL, INC. |
1046 Calle Recodo Ste G
| San Clemente |
CA |
92673 |
K983265 |
DEPUY ACE MEDICAL CO. |
2260 EAST EL SEGUNDO BLVD.
| EL SEGUNDO |
CA |
90245 |
K983906 |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE
| WARSAW |
IN |
46581-0988 |
K991135 |
DEPUY, INC. |
700 ORTHOPAEDIC DR.
| WARSAW |
IN |
46581-0988 |
K200332 |
GM dos Reis Industria e Comercio Ltda |
Avenida Pierre Simon de La Place 600
| Campinas |
|
13069320 |
K220260 |
In2Bones USA, LLC |
6000 Poplar Ave, Suite 115
| Memphis |
TN |
38119 |
K111032 |
INSTRATEK, INC. |
4141 DIRECTORS ROW
| HOUSTON |
TX |
77092 |
K082384 |
INSTRATEK, INC. |
210 SPRINGHILL DR.
| SPRING |
TX |
77386 |
K091763 |
INSTRATEK, INC. |
210 SPRINGHILL DR.
| SPRING |
TX |
77386 |
K954682 |
LINVATEC CORP. |
11311 CONCEPT BLVD.
| LARGO |
FL |
33773-4908 |
K211612 |
Medline Industries, Inc. |
Three Lakes Drive
| Northfield |
IL |
60093 |
K141420 |
MEDSHAPE, INC |
1575 NORTHSIDE DRIVE,
| ATLANTA |
GA |
30318 |
K172620 |
Mortise Medical LLC |
124 South 600 West
| Logan |
UT |
84321 |
K132733 |
ORTHOHELIX SURGICAL DESIGNS, INC. |
1065 Medina Rd.
| Medina |
OH |
44256 |
K963420 |
ORTHOPAEDIC BIOSYSTEMS, LTD. |
7320 EAST BUTHERUS
| SCOTSDALE |
AZ |
85260 |
K030619 |
ORTHOPEDIC DESIGNS, INC. |
6965 1ST. AVE. NORTH
| ST. PETERSBURG |
FL |
33710-8303 |
K171703 |
Panther Orthopedics, Inc. |
5279 Apennines Circle
| San Jose |
CA |
95138 |
K003496 |
PIONEER SURGICAL TECHNOLOGY |
375 RIVER PARK CIRCLE
| MARQUETTE |
MI |
49855-0627 |
K992617 |
PIONEER SURGICAL TECHNOLOGY |
375 RIVER PARK CIRCLE
| MARQUETTE |
MI |
49855-0627 |
K043411 |
RESOFIX, INC. |
5349 RED LEAF COURT
| OVIEDO |
FL |
32765 |
K082095 |
SMITH & NEPHEW ENDOSCOPY, INC. |
150 Minuteman Road
| Andover |
MA |
01810 |
K162996 |
SMITH & NEPHEW, INC. |
150 MINUTEMAN ROAD
| ANDOVER |
MA |
01810 |
K183232 |
Smith and Nephew, Inc. |
150 Minuteman Road
| Andover |
MA |
01810 |
K982354 |
SPECIAL DEVICES, INC. |
12493 OLD ROUGH AND READY HWY.
| GRASS VALLEY |
CA |
95945 |
K091207 |
SURGICRAFT LTD. |
111 HILL ROAD
| DOUGLASSVILLE |
PA |
19518 |
K011583 |
SYNTHES (USA) |
1690 RUSSELL RD.
| PAOLI |
PA |
19301 |
K013806 |
SYNTHES (USA) |
1690 RUSSELL RD.
| PAOLI |
PA |
19301 |
K980944 |
SYNTHES (USA) |
1690 RUSSELL RD.
| PAOLI |
PA |
19301 |
K040250 |
TRIAGE MEDICAL INC |
13700 ALTON PKWY.
| IRVINE |
CA |
92618 |
K220650 |
TriMed, Inc. |
27533 Avenue Hopkins
| Santa Clarita |
CA |
91355 |
K170249 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
1023 CHERRY ROAD
| MEMPHIS |
TN |
38117 |
K180243 |
Xiros Ltd |
Springfield House, Whitehouse Lane
| Leeds |
|
LS17 7UE |
K091799 |
ZIMMER, INC. |
P.O. BOX 708
| WARSAW |
IN |
46581-0708 |
|
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