The following data is part of a premarket notification filed by Integra Life Sciences Corporation with the FDA for Integra Freedom Wrist Arthroplasty System.
| Device ID | K132250 |
| 510k Number | K132250 |
| Device Name: | INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM |
| Classification | Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained |
| Applicant | INTEGRA LIFE SCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Frederic Testa |
| Correspondent | Frederic Testa INTEGRA LIFE SCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Product Code | JWJ |
| CFR Regulation Number | 888.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-19 |
| Decision Date | 2014-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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