Cleared Traditional

K072291 - CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR
(FDA 510(k) Clearance)

K072291 · Conmed Linvatec · Orthopedic

Jul 2008

Decision

333d

Days

Class 2

Risk

K072291 is an FDA 510(k) clearance for the CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on July 14, 2008, 333 days after receiving the submission on August 16, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K072291 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2007
Decision Date	July 14, 2008
Days to Decision	333 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF