The following data is part of a premarket notification filed by Spine Next America Corporation with the FDA for Fidji-vertebral Body Replacement Type 5.
| Device ID | K042713 |
| 510k Number | K042713 |
| Device Name: | FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5 |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SPINE NEXT AMERICA CORPORATION 8381 DIX ELLIS TRAIL, STE. 110 Jacksonville, FL 32256 |
| Contact | Tom Brewer |
| Correspondent | Tom Brewer SPINE NEXT AMERICA CORPORATION 8381 DIX ELLIS TRAIL, STE. 110 Jacksonville, FL 32256 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-30 |
| Decision Date | 2004-12-29 |
| Summary: | summary |