The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Mash.
| Device ID | K023319 |
| 510k Number | K023319 |
| Device Name: | NUVASIVE MASH |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
| Contact | Laetitia Bernard |
| Correspondent | Laetitia Bernard NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-04 |
| Decision Date | 2003-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517054999 | K023319 | 000 |
| 00887517055415 | K023319 | 000 |
| 00887517055422 | K023319 | 000 |
| 00887517055439 | K023319 | 000 |
| 00887517055446 | K023319 | 000 |
| 00887517055453 | K023319 | 000 |
| 00887517055460 | K023319 | 000 |
| 00887517055477 | K023319 | 000 |
| 00887517055484 | K023319 | 000 |
| 00887517055408 | K023319 | 000 |
| 00887517054982 | K023319 | 000 |
| 00887517055866 | K023319 | 000 |
| 00887517054913 | K023319 | 000 |
| 00887517054920 | K023319 | 000 |
| 00887517054937 | K023319 | 000 |
| 00887517054944 | K023319 | 000 |
| 00887517054951 | K023319 | 000 |
| 00887517054968 | K023319 | 000 |
| 00887517054975 | K023319 | 000 |
| 00887517055491 | K023319 | 000 |
| 00887517055804 | K023319 | 000 |
| 00887517055811 | K023319 | 000 |
| 00887517056337 | K023319 | 000 |
| 00887517056344 | K023319 | 000 |
| 00887517056351 | K023319 | 000 |
| 00887517063496 | K023319 | 000 |
| 00887517063908 | K023319 | 000 |
| 00887517063915 | K023319 | 000 |
| 00887517063922 | K023319 | 000 |
| 00887517063939 | K023319 | 000 |
| 00887517056320 | K023319 | 000 |
| 00887517056313 | K023319 | 000 |
| 00887517055828 | K023319 | 000 |
| 00887517055835 | K023319 | 000 |
| 00887517055842 | K023319 | 000 |
| 00887517055859 | K023319 | 000 |
| 00887517055873 | K023319 | 000 |
| 00887517055880 | K023319 | 000 |
| 00887517055897 | K023319 | 000 |
| 00887517056306 | K023319 | 000 |
| 00887517063946 | K023319 | 000 |