FDA 510(k) Applications for Medical Device:
Washer, Bolt Nut
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K243624 | Acumed LLC |
5885 NE Cornelious Pass | Hillsboro | OR | 97124 |
| 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 |
| K232780 | CC-Instruments Inc |
850 New Burton Road | Dover | DE | 19904 |
| 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 |
| K242091 | Fusion Orthopedics |
6859 E Rembrandt Ave Suite 122 | Mesa | AZ | 85212 |
| K240947 | Globus Medical, Inc |
Valley Forge Business Center | Audubon | PA | 19403 |
| K200332 | GM dos Reis Industria e Comercio Ltda |
Avenida Pierre Simon de La Place 600 | Campinas | 13069320 | |
| K242311 | 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 |
| K233531 | Orthopaedic Implant Company |
770 Smithridge Dr. #400 | Reno | NV | 89502 |
| 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 |
| K251134 | TriMed, Inc. |
27533 Avenue Hopkins | Santa Clarita | CA | 91355 |
| K220650 | TriMed, Inc. |
27533 Avenue Hopkins | Santa Clarita | CA | 91355 |
| K240035 | Vilex LLC |
111 Moffitt Street | McMinnville | TN | 37110 |
| K243408 | Vilex LLC |
111 Moffitt Street | McMinnville | TN | 37110 |
| 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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