510(k) K163672

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor by Nanova Biomaterials, Inc. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2017
Date Received
December 27, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type