Cleared Traditional

Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor

K163672 · Nanova Biomaterials, Inc. · Orthopedic

May 2017

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K163672 is an FDA 510(k) clearance for the Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Nanova Biomaterials, Inc. (Columbia, US). The FDA issued a Cleared decision on May 5, 2017, 129 days after receiving the submission on December 27, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K163672 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2016
Decision Date	May 05, 2017
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF