The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive(r) Monolith Corpectomy System.
| Device ID | K170271 |
| 510k Number | K170271 |
| Device Name: | NuVasive(r) Monolith Corpectomy System |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Contact | Cynthia Adams |
| Correspondent | Cynthia Adams NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-27 |
| Decision Date | 2017-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517950390 | K170271 | 000 |
| 00887517677471 | K170271 | 000 |
| 00887517677464 | K170271 | 000 |
| 00887517677457 | K170271 | 000 |
| 00887517677440 | K170271 | 000 |
| 00887517624338 | K170271 | 000 |
| 00887517624321 | K170271 | 000 |
| 00887517624314 | K170271 | 000 |
| 00887517624307 | K170271 | 000 |