The following data is part of a premarket notification filed by Zimmer Trabecular Metal Technology with the FDA for Trabecular Metal Glenoid- B/f Complete Shoulder Solution.
| Device ID | K071090 |
| 510k Number | K071090 |
| Device Name: | TRABECULAR METAL GLENOID- B/F COMPLETE SHOULDER SOLUTION |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
| Contact | Kathleen Rutherford |
| Correspondent | Kathleen Rutherford ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-18 |
| Decision Date | 2007-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024306707 | K071090 | 000 |
| 00889024306691 | K071090 | 000 |
| 00889024306684 | K071090 | 000 |
| 00889024306677 | K071090 | 000 |
| 00889024306660 | K071090 | 000 |
| 00889024306653 | K071090 | 000 |
| 00889024306646 | K071090 | 000 |
| 00889024306639 | K071090 | 000 |