Cleared Traditional

REVERTO 55 AND 37 SHAPE MEMORY STAPLES

K071477 · Core Essence Orthopaedics, LLC · Orthopedic

Aug 2007

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K071477 is an FDA 510(k) clearance for the REVERTO 55 AND 37 SHAPE MEMORY STAPLES, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Core Essence Orthopaedics, LLC (Yardley, US). The FDA issued a Cleared decision on August 15, 2007, 78 days after receiving the submission on May 29, 2007. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K071477 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 2007
Decision Date	August 15, 2007
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF