The following data is part of a premarket notification filed by Zimmer Trabecular with the FDA for Trabecular Metal Acetabular Augments, Models 4894-xxx-yy, 02-212-105xx3, 02-212-205xx3, 02-212-305xx3.
| Device ID | K042871 |
| 510k Number | K042871 |
| Device Name: | TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 |
| 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 | 2004-10-18 |
| Decision Date | 2004-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024306974 | K042871 | 000 |
| 00889024306851 | K042871 | 000 |
| 00889024306844 | K042871 | 000 |
| 00889024306837 | K042871 | 000 |
| 00889024306820 | K042871 | 000 |
| 00889024306813 | K042871 | 000 |
| 00889024306806 | K042871 | 000 |
| 00889024306790 | K042871 | 000 |
| 00889024306783 | K042871 | 000 |
| 00889024306776 | K042871 | 000 |
| 00889024306868 | K042871 | 000 |
| 00889024306875 | K042871 | 000 |
| 00889024306967 | K042871 | 000 |
| 00889024306950 | K042871 | 000 |
| 00889024306943 | K042871 | 000 |
| 00889024306936 | K042871 | 000 |
| 00889024306929 | K042871 | 000 |
| 00889024306912 | K042871 | 000 |
| 00889024306905 | K042871 | 000 |
| 00889024306899 | K042871 | 000 |
| 00889024306882 | K042871 | 000 |
| 00889024306769 | K042871 | 000 |