The following data is part of a premarket notification filed by Zimmer Trabecular Metal Technology with the FDA for Trabecular Metal (tm) Vertebral Body Replacement (vbr) System Instrument Set.
| Device ID | K093127 |
| 510k Number | K093127 |
| Device Name: | TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
| Contact | Kathleen Rutherford |
| Correspondent | Kathleen Rutherford ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-02 |
| Decision Date | 2010-03-04 |
| Summary: | summary |