The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Attrax Scaffold.
| Device ID | K172497 |
| 510k Number | K172497 |
| Device Name: | NuVasive AttraX Scaffold |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Marysa E. Loustalot |
| Correspondent | Martin Yahiro, Md NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-18 |
| Decision Date | 2017-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517940025 | K172497 | 000 |
| 00887517940018 | K172497 | 000 |
| 00887517940001 | K172497 | 000 |
| 00887517939999 | K172497 | 000 |
| 00887517939982 | K172497 | 000 |
| 00887517939975 | K172497 | 000 |
| 00887517939968 | K172497 | 000 |
| 00887517939951 | K172497 | 000 |