The following data is part of a premarket notification filed by Atlas Spine Inc. with the FDA for Atlas Spine Vertebral Body Replacement.
| Device ID | K063464 |
| 510k Number | K063464 |
| Device Name: | ATLAS SPINE VERTEBRAL BODY REPLACEMENT |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | ATLAS SPINE INC. 1555 JUPITER PARK DR., STE. 4 Jupiter, FL 33458 |
| Contact | Jeannette G Dailey |
| Correspondent | Jeannette G Dailey ATLAS SPINE INC. 1555 JUPITER PARK DR., STE. 4 Jupiter, FL 33458 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-16 |
| Decision Date | 2007-03-09 |
| Summary: | summary |