The following data is part of a premarket notification filed by Zimmer Trabecular with the FDA for The Trabecular Metal Glenoid - Bigliani/flatow The Complete Shoulder Solution, Model 4316-xx-xx.
| Device ID | K043061 |
| 510k Number | K043061 |
| Device Name: | THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
| Contact | Marci Halevi |
| Correspondent | Marci Halevi ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-05 |
| Decision Date | 2004-11-23 |
| Summary: | summary |