FDA 510(k) Applications for Medical Device:
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K182878 | Ascension Orthopedics |
11101 Metric Blvd. | Austin | TX | 78758 |
| K151459 | Ascension Orthopedics |
8700 Cameron Road, Suite 100 | Austin | TX | 78754 |
| K053569 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K122395 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K020541 | DEPUY, INC. |
700 ORTHOPAEDIC DR. | WARSAW | IN | 46581 |
| K171004 | Dt MedTech LLC |
110 West Road | Towson | MD | 21024 |
| K152217 | EXACTECH INC |
2320 NW 66TH COURT | GAINESVILLE | FL | 32653 |
| K183343 | Exactech Inc |
2320 NW 66th Court | Gainesville | FL | 32653 |
| K232002 | Exactech Inc. |
2320 NW 66th Court | Gainesville | FL | 32653 |
| K230717 | Exactech, Inc. |
2320 NW 66th Ct. | Gainesville | FL | 32653 |
| K230313 | In2Bones SAS |
26 Chemin du Petit Bois | Ecully | 69130 | |
| K211883 | In2Bones SAS |
26 Chemin du Petit Bois | Ecully | 69130 | |
| K231699 | In2Bones SAS |
26 Chemin du Petit Bois | Ecully | 69130 | |
| K191380 | In2Bones SAS |
| Ecully | 69130 | |
| K201507 | Integra Lifesciences Corporation |
11101 Metric Blvd | Austin | TX | 78758 |
| K061749 | KINETIKOS MEDICAL, INC. |
6005 HIDDEN VALLEY RD, STE 180 | CARLSBAD | CA | 92011 |
| K192778 | Kinos Medical |
992 Old Eagle School Road Suite 907 | Wayne | PA | 19087 |
| K223227 | Paragon 28, Inc |
14445 Grasslands Drive | Englewood | CO | 80112 |
| K250641 | Paragon 28, Inc. |
14445 Grasslands Dr | Englewood | CO | 80112 |
| K202373 | Paragon 28, Inc. |
14445 Grasslands Dr. | Englewood | CA | 80112 |
| K210390 | Paragon 28, Inc. |
14445 Grasslands Dr. | Englewood | CO | 80112 |
| K240259 | Paragon 28, Inc. |
14445 Grasslands Drive | Englewood | CO | 80112 |
| K202019 | Paragon 28, Inc. |
14445 Grasslands Dr. | Englewood | CO | 80112 |
| K192994 | Paragon 28, Inc. |
4B Inverness Ct. E., STE 280 | Englewood | CO | 80112 |
| K232595 | restor3d |
4001 E. NC 54 Highway | Durham | NC | 27709 |
| K241482 | restor3d |
4001 NC 54 Highway | Durham | NC | 27709 |
| K242868 | restor3d |
4001 NC 54 Highway | Durham | NC | 27709 |
| K240591 | restor3d, Inc. |
4001 E. NC 54 Highway | Durham | NC | 27709 |
| K051023 | TOPEZ ORTHOPEDICS, INC |
4655 KIRKWOOD COURT | BOULDER | CO | 80301 |
| K090076 | TORNIER |
161 RUE LAVOISIER | SAINT-ISMIER CEDEX | 38334 | |
| K060544 | TORNIER |
RUE DOYEN GOSSE | ST. ISMIER | 38330 | |
| K130533 | Tornier SAS |
161 RUE LAVOISIER | MONTBONNOT SAINT MARTIN | 38330 | |
| K153452 | Tornier SAS |
161 rue Lavoisier | Montbonnot St. Martin | 38330 | |
| K240475 | Vilex, LLC |
111 Moffitt St. | McMinnville | TN | 37110 |
| K230462 | Vilex, LLC |
111 Moffitt Street | McMinnville | TN | 37110 |
| K241999 | Wright Medical Technology, Inc (Stryker) |
1023 Cherry Road | Memphis | TN | 38117 |
| K123059 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K100886 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K133585 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K103374 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K141740 | WRIGHT MEDICAL TECHNOLOGY, INC. |
1023 CHERRY ROAD | MEMPHIS | TN | 38117 |
| K140749 | WRIGHT MEDICAL TECHNOLOGY, INC. |
1023 CHERRY ROAD | MEMPHIS | TN | 38117 |
| K172633 | Wright Medical Technology, Inc. |
1023 Cherry Road | Memphis | TN | 38117 |
| K181557 | Wright Medical Technology, Inc. |
1023 Cherry Road | Memphis | TN | 38117 |
| K123954 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K191393 | Wright Medical Technology, Inc. |
1023 Cherry Road | Memphis | TN | 38117 |
| K142117 | WRIGHT MEDICAL TECHNOLOGY, INC. |
1023 CHERRY ROAD | MEMPHIS | TN | 38117 |
| K153008 | Wright Medical Technology, Inc. |
1023 Cherry Road | Memphis | TN | 38117 |
| K171067 | Wright Medical Technology, Inc. |
1023 Cherry Road | Memphis | TN | 38117 |
| K180730 | Wright Medical Technology, Inc. |
1023 Cherry Road | Memphis | TN | 38117 |
| K110360 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K131283 | WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. | ARLINGTON | TN | 38002 |
| K170968 | Wright Medical Technology, Inc. |
1023 Cherry Road | Memphis | TN | 38117 |
| K162795 | Wright Medical Technology, Inc. |
1023 Cherry Road | Memphis | TN | 37117 |
| K202815 | Wright Medical Technology, Inc. |
10801 Nesbitt Ave S | Bloomington | MN | 55437 |
| K222835 | Wright Medical Technology, Inc. |
10801 Nesbitt Ave S. | Bloomington | MN | 55437 |
| K193067 | Wright Medical Technology, Inc. |
1023 Cherry Road | Memphis | TN | 38117 |
| K250037 | Wright Medical Technology, Inc. (Stryker) |
1023 Cherry Road | Memphis | TN | 38117 |
| K120906 | ZIMMER, INC. |
P.O. BOX 708 | WARSAW | IN | 46581-0708 |
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