The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Sterilization Trays.
Device ID | K143579 |
510k Number | K143579 |
Device Name: | NuVasive Sterilization Trays |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
Contact | Olga Lewis |
Correspondent | Olga Lewis NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-18 |
Decision Date | 2015-08-28 |
Summary: | summary |