The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Helix Mini Acp System.
| Device ID | K073275 |
| 510k Number | K073275 |
| Device Name: | NUVASIVE HELIX MINI ACP SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
| Contact | Laetitia Cousin |
| Correspondent | Laetitia Cousin NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-21 |
| Decision Date | 2008-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517097651 | K073275 | 000 |
| 00887517096265 | K073275 | 000 |
| 00887517096258 | K073275 | 000 |
| 00887517096241 | K073275 | 000 |
| 00887517096234 | K073275 | 000 |
| 00887517096227 | K073275 | 000 |
| 00887517096210 | K073275 | 000 |
| 00887517096203 | K073275 | 000 |
| 00887517095794 | K073275 | 000 |
| 00887517095787 | K073275 | 000 |
| 00887517095770 | K073275 | 000 |
| 00887517095763 | K073275 | 000 |
| 00887517095756 | K073275 | 000 |
| 00887517095749 | K073275 | 000 |
| 00887517095732 | K073275 | 000 |
| 00887517091796 | K073275 | 000 |
| 00887517096272 | K073275 | 000 |
| 00887517096289 | K073275 | 000 |
| 00887517097644 | K073275 | 000 |
| 00887517097637 | K073275 | 000 |
| 00887517097620 | K073275 | 000 |
| 00887517097613 | K073275 | 000 |
| 00887517097606 | K073275 | 000 |
| 00887517097293 | K073275 | 000 |
| 00887517097286 | K073275 | 000 |
| 00887517097279 | K073275 | 000 |
| 00887517097231 | K073275 | 000 |
| 00887517097224 | K073275 | 000 |
| 00887517097217 | K073275 | 000 |
| 00887517096784 | K073275 | 000 |
| 00887517096777 | K073275 | 000 |
| 00887517096760 | K073275 | 000 |
| 00887517096296 | K073275 | 000 |
| 00887517096791 | K073275 | 000 |