Cleared Traditional

RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X

K071520 · Core Essence Orthopaedics, LLC · Orthopedic

Aug 2007

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K071520 is an FDA 510(k) clearance for the RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Core Essence Orthopaedics, LLC (Yardley, US). The FDA issued a Cleared decision on August 10, 2007, 67 days after receiving the submission on June 4, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K071520 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2007
Decision Date	August 10, 2007
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF