FDA 510(k) Applications for Medical Device:
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K200718 | Arthrosurface, Inc. |
28 Forge Parkway | Franklin | MA | 02038 |
| K233674 | Ascension Orthopedics, Inc. |
11101 Metric Blvd. | Austin | TX | 78758 |
| K021859 | AVANTA ORTHOPAEDICS, INC. |
9369 CARROLL PARK DRIVE, STE.A | SAN DIEGO | CA | 92121 |
| K080426 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46581-0587 |
| K042032 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K031203 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K191525 | Extremity Medical, LLC. |
300 Interpace Parkway, Suite 410 | Parsippany | NJ | 07054 |
| K132250 | INTEGRA LIFE SCIENCES CORPORATION |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K020554 | KINETIKOS MEDICAL, INC. |
4329 GRAYDON RD. | SAN DIEGO | CA | 92130 |
| K030037 | KINETIKOS MEDICAL, INC. |
6005 HIDDEN VALLEY RD, STE 180 | CARLSBAD | CA | 92011 |
| K961051 | KINETIKOS MEDICAL, INC. |
3950 SORRENTO VALLEY BLVD., | SAN DIEGO | CA | 92121 |
| K982156 | PASCO LABORATORIES, INC. |
12750 WEST 42ND AVE. | WHEAT RIDGE | CO | 80033 |
| K233574 | Skeletal Dynamics |
7300 N Kendall Dr | Miami | FL | 33156 |
| K243381 | Skeletal Dynamics Inc |
7300 N Kendall Dr | Miami | FL | 33156 |
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