The following data is part of a premarket notification filed by Zimmer Trabecular with the FDA for Trabecular Metal Acetabular Revision Shells.
| Device ID | K050937 |
| 510k Number | K050937 |
| Device Name: | TRABECULAR METAL ACETABULAR REVISION SHELLS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-14 |
| Decision Date | 2005-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024310995 | K050937 | 000 |
| 00889024310988 | K050937 | 000 |
| 00889024310971 | K050937 | 000 |
| 00889024310964 | K050937 | 000 |
| 00889024310957 | K050937 | 000 |