The following data is part of a premarket notification filed by New Business Development, Llc with the FDA for Phenix Vertebral Body Replacement.
| Device ID | K072029 |
| 510k Number | K072029 |
| Device Name: | PHENIX VERTEBRAL BODY REPLACEMENT |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | NEW BUSINESS DEVELOPMENT, LLC 1155 ALLGOOD RD. SUITE 6 Marietta, GA 30062 |
| Contact | Tim B Lusby |
| Correspondent | Tim B Lusby NEW BUSINESS DEVELOPMENT, LLC 1155 ALLGOOD RD. SUITE 6 Marietta, GA 30062 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-24 |
| Decision Date | 2007-10-15 |
| Summary: | summary |