Cleared Traditional

K011137 - RESORBABLE HAMMERTOE PIN (FDA 510(k) Clearance)

K011137 · Biomet, Inc. · Orthopedic device

Jun 2001

Decision

67d

Days

Class 2

Risk

K011137 is an FDA 510(k) clearance for the RESORBABLE HAMMERTOE PIN. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 19, 2001, 67 days after receiving the submission on April 13, 2001.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K011137 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 13, 2001
Decision Date	June 19, 2001
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF