The following data is part of a premarket notification filed by Spinal Usa with the FDA for Spinal Usa Interbody Fusion Device.
| Device ID | K080314 |
| 510k Number | K080314 |
| Device Name: | SPINAL USA INTERBODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINAL USA 644 LAKELAND EAST DR., STE. A Flowood, MS 39232 |
| Contact | Jeffrey Johnson |
| Correspondent | Jeffrey Johnson SPINAL USA 644 LAKELAND EAST DR., STE. A Flowood, MS 39232 |
| Product Code | MAX |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-06 |
| Decision Date | 2008-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815362023211 | K080314 | 000 |
| 00840019929455 | K080314 | 000 |
| 00840019929431 | K080314 | 000 |
| 00840019929424 | K080314 | 000 |
| 00840019929417 | K080314 | 000 |
| 00840019929400 | K080314 | 000 |
| 00840019929394 | K080314 | 000 |
| 00840019929387 | K080314 | 000 |
| 00840019929370 | K080314 | 000 |
| 00840019929363 | K080314 | 000 |
| 00840019929356 | K080314 | 000 |
| 00840019929349 | K080314 | 000 |
| 00840019929332 | K080314 | 000 |
| 00840019929325 | K080314 | 000 |
| 00840019929318 | K080314 | 000 |
| 00840019929301 | K080314 | 000 |
| 00840019929288 | K080314 | 000 |
| 00840019929448 | K080314 | 000 |
| 00815362023020 | K080314 | 000 |
| 00815362023037 | K080314 | 000 |
| 00815362023204 | K080314 | 000 |
| 00815362023198 | K080314 | 000 |
| 00815362023181 | K080314 | 000 |
| 00815362023174 | K080314 | 000 |
| 00815362023167 | K080314 | 000 |
| 00815362023150 | K080314 | 000 |
| 00815362023143 | K080314 | 000 |
| 00815362023136 | K080314 | 000 |
| 00815362023129 | K080314 | 000 |
| 00815362023112 | K080314 | 000 |
| 00815362023105 | K080314 | 000 |
| 00815362023099 | K080314 | 000 |
| 00815362023082 | K080314 | 000 |
| 00815362023075 | K080314 | 000 |
| 00815362023068 | K080314 | 000 |
| 00815362023051 | K080314 | 000 |
| 00815362023044 | K080314 | 000 |
| 00840019929295 | K080314 | 000 |