The following data is part of a premarket notification filed by Zimmer Trabecular Metal Technology with the FDA for Trabecular Metal Vertebral Body Replacement (vbr), Model# 06-115, 06-155.
| Device ID | K070754 |
| 510k Number | K070754 |
| Device Name: | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155 |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | ZIMMER TRABECULAR METAL TECHNOLOGY 10 POMEROY RD. Parsippany, NJ 07054 |
| Contact | Jennifer P Harakal |
| Correspondent | Jennifer P Harakal 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 | 2007-03-19 |
| Decision Date | 2007-08-31 |
| Summary: | summary |