The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Attrax Putty.
Device ID | K191974 |
510k Number | K191974 |
Device Name: | NuVasive AttraX Putty |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
Contact | Jessica Leblanc |
Correspondent | Jessica Leblanc 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 | 2019-07-24 |
Decision Date | 2019-11-03 |