The following data is part of a premarket notification filed by Zimmer Trabecular Metal Technology, Inc. with the FDA for Tm-400 Device.
| Device ID | K120203 |
| 510k Number | K120203 |
| Device Name: | TM-400 DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ZIMMER TRABECULAR METAL TECHNOLOGY, INC. 10 POMEROY RD. Parsippany, NJ 07054 |
| Contact | Kathleen Rutherford |
| Correspondent | Kathleen Rutherford ZIMMER TRABECULAR METAL TECHNOLOGY, INC. 10 POMEROY RD. Parsippany, NJ 07054 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-23 |
| Decision Date | 2012-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024320536 | K120203 | 000 |
| 00889024320529 | K120203 | 000 |
| 00889024320512 | K120203 | 000 |
| 00889024320505 | K120203 | 000 |
| 00889024320499 | K120203 | 000 |
| 00889024320482 | K120203 | 000 |
| 00889024319653 | K120203 | 000 |