Cleared Traditional

STRYKER SONICPIN SYSTEM

K091955 · Howmedica Osteonics Corp. · Orthopedic
Apr 2010
Decision
275d
Days
Class 2
Risk

About This 510(k) Submission

K091955 is an FDA 510(k) clearance for the STRYKER SONICPIN SYSTEM, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on April 2, 2010, 275 days after receiving the submission on July 1, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K091955 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2009
Decision Date April 02, 2010
Days to Decision 275 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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