Cleared Traditional

K002125: PINS AND WIRES

K002125 · Implant Resource, Inc. · Orthopedic

Oct 2000

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K002125 is an FDA 510(k) clearance for the PINS AND WIRES, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Implant Resource, Inc. (Prior Lake, US). The FDA issued a Cleared decision on October 11, 2000, 89 days after receiving the submission on July 14, 2000. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K002125 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 2000
Decision Date	October 11, 2000
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF