The following data is part of a premarket notification filed by Zimmer Trabecular with the FDA for The Zimmer Tmt Trabecular Metal Vertebral Body Replacement System.
| Device ID | K052950 |
| 510k Number | K052950 |
| Device Name: | THE ZIMMER TMT TRABECULAR METAL VERTEBRAL BODY REPLACEMENT SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| 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 | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-20 |
| Decision Date | 2005-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024314276 | K052950 | 000 |
| 00889024314269 | K052950 | 000 |
| 00889024314252 | K052950 | 000 |
| 00889024314245 | K052950 | 000 |
| 00889024314238 | K052950 | 000 |
| 00889024314221 | K052950 | 000 |
| 00889024314214 | K052950 | 000 |
| 00889024314207 | K052950 | 000 |