Cleared Traditional

K051740 - TAPERED COMPRESSION PIN
(FDA 510(k) Clearance)

Sep 2005
Decision
70d
Days
Class 2
Risk

K051740 is an FDA 510(k) clearance for the TAPERED COMPRESSION PIN. This device is classified as a Pin, Fixation, Threaded (Class II - Special Controls, product code JDW).

Submitted by Nexa Orthopedics, Inc. (Vista, US). The FDA issued a Cleared decision on September 6, 2005, 70 days after receiving the submission on June 28, 2005.

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

Submission Details

510(k) Number K051740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2005
Decision Date September 06, 2005
Days to Decision 70 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDW — Pin, Fixation, Threaded
Device Class Class II - Special Controls
CFR Regulation 21 CFR 888.3040

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