The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Triad Facet Screw System.
Device ID | K020411 |
510k Number | K020411 |
Device Name: | NUVASIVE TRIAD FACET SCREW SYSTEM |
Classification | System, Facet Screw Spinal Device |
Applicant | NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
Contact | Laetitia Bernard |
Correspondent | Laetitia Bernard NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
Product Code | MRW |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-07 |
Decision Date | 2002-03-12 |
Summary: | summary |