The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Peek Corpectomy System.
| Device ID | K151167 |
| 510k Number | K151167 |
| Device Name: | NuVasive PEEK Corpectomy System |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
| Contact | Olga Lewis |
| Correspondent | Olga Lewis NUVASIVE, INCORPORATED 7475 LUSK BLVD. 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 | 2015-05-01 |
| Decision Date | 2015-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517624628 | K151167 | 000 |