FDA 510(k) Applications for Medical Device:
Prosthesis, Toe, Hemi-, Phalangeal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K200951 | Accufix Surgical, Inc. |
385 Main Street, Suite 10 | West Haven | CT | 06516 |
| K063058 | ARTHREX, INC. |
1370 CREEKSIDE BLVD. | NAPLES | FL | 34108-1945 |
| K190261 | Arthrosurface, Inc. |
38 Forge Parkway | Franklin | MA | 02038 |
| K063370 | ARTHROSURFACE, INC. |
28 FORGE PARKWAY | FRANKLIN | MA | 02038 |
| K031859 | ARTHROSURFACE, INC. |
378 PAGE STREET, STE 6 | STOUGHTON | MA | 02072 |
| K131377 | ARTHROSURFACE, INC. |
28 FORGE PARKWAY | FRANKLIN | MA | 02038 |
| K152454 | ARTHROSURFACE, INC. |
28 FORGE PARKWAY | FRANKLIN | MA | 02038 |
| K092047 | ASCENSION ORTHOPEDICS, INC. |
8700 CAMERON RD., STE. 100 | AUSTIN | TX | 78754-3832 |
| K060560 | ASCENSION ORTHOPEDICS, INC. |
8700 CAMERON RD., STE. 100 | AUSTIN | TX | 78754-3832 |
| K203634 | BioPoly, LLC |
7136 Gettysburg Pike | Fort Wayne | IN | 46804 |
| K222964 | BioPoly, LLC |
7136 Gettysburg Pike | Fort Wayne | IN | 46804 |
| K121973 | BIOPRO, INC. |
3150 E. 200TH ST | PRIOR LAKE | MN | 55372 |
| K041595 | BIOPRO, INC. |
17 SEVENTEENTH ST. | PORT HURON | MI | 48060 |
| K014164 | HARMOS ORTHOPAEDICS, INC. |
1002 FREDERICK RD. | CATONSVILLE | MD | 21228 |
| K023770 | KINETIKOS MEDICAL, INC. |
4115 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K161279 | LIFE SPINE INC. |
13951 S QUALITY DRIVE | HUNTLEY | IL | 60142 |
| K083469 | METASURG |
16350 PARK TEN PL., SUITE 101 | HOUSTON | TX | 77084 |
| K221220 | Montross Extremity Medical |
20 Belle Air Rd | Colorado Springs | CO | 80906 |
| K971047 | NEXA ORTHOPEDICS, INC. |
9369 CARROLL PARK DR., SUITE A | SAN DIEGO | CA | 92121 |
| K071243 | ORTHOPRO LLC |
1001 OAKWOOD BLVD. | ROUND ROCK | TX | 78681 |
| K062908 | ORTHOPRO LLC |
1001 OAKWOOD BLVD. | ROUND ROCK | TX | 78681 |
| K060536 | OSTEOMED L.P. |
3885 ARAPAHO RD. | ADDISON | TX | 75001 |
| K073065 | OSTEOMED L.P. |
3885 ARAPAHO RD. | ADDISON | TX | 75001 |
| K081876 | OSTEOMED L.P. |
3885 ARAPAHO RD. | ADDISON | TX | 75001 |
| K201393 | Restor3d, Inc. |
311 W Corporation St | Durham | NC | 27701 |
| K021063 | SIGNAL MEDICAL CORP. |
3777 LAPEER RD. 3-C | PORT HURON | MI | 48060 |
| K073635 | SMALL BONE INNOVATIONS INC. |
1331 H STREET NW, 12TH FL | WASHINGTON | DC | 20005 |
| K062040 | SMALL BONE INNOVATIONS INC. |
505 PARK AVE., 14TH FLOOR | NEW YORK | NY | 10022 |
| K120029 | SOLANA SURGICAL LLC |
6363 POPLAR AVE | MEMPHIS | TN | 38119 |
| K113752 | SOLANA SURGICAL LLC |
6363 POPLAR AVE | MEMPHIS | TN | 38119 |
| K090127 | SOLANA SURGICAL LLC |
1828 BAILEY DRIVE | OCEANSIDE | CA | 92056 |
| K131187 | SOLANA SURGICAL, LLC |
6363 POPLAR AVENUE | MEMPHIS | TN | 38119 |
| K003629 | TERRAY CORP. |
49 JACKSON LANE | ARNPRIOR, ONTARIO | K7S 3G8 | |
| K072922 | TRILLIANT SURGICAL LTD |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K190543 | Vilex in Tennessee, Inc. |
111 Moffitt Street | McMinnville | TN | 37110 |
| K023684 | VILEX, INC. |
345 OLD CURRY HOLLOW RD. | PLEASANT HILLS | PA | 15236 |
| K102401 | VILEX, INC. |
111 MOFFITT STREET | MCMINNVILLE | TN | 37110 |
| K070052 | VILEX, INC. |
345 OLD CURRY HOLLOW RD. | PITTSBURGH | PA | 15236 |
| K030319 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
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