The following data is part of a premarket notification filed by Zimmer Trabecular with the FDA for Trabecular Metal Acetabular Augments.
| Device ID | K061067 |
| 510k Number | K061067 |
| Device Name: | TRABECULAR METAL ACETABULAR AUGMENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
| Contact | Robert A Poggie |
| Correspondent | Robert A Poggie ZIMMER TRABECULAR 80 COMMERCE DR. Allendale, NJ 07401 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-17 |
| Decision Date | 2006-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024306998 | K061067 | 000 |
| 00889024306981 | K061067 | 000 |
| 00889024306752 | K061067 | 000 |
| 00889024306745 | K061067 | 000 |
| 00889024306738 | K061067 | 000 |
| 00889024306721 | K061067 | 000 |
| 00889024306714 | K061067 | 000 |