Cleared Traditional

3.7MM/5.0MM DYNAMIC LOCKING SCREW

K110592 · Synthes (Usa) · Orthopedic
Jul 2011
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K110592 is an FDA 510(k) clearance for the 3.7MM/5.0MM DYNAMIC LOCKING SCREW, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Synthes (Usa) (19380, US). The FDA issued a Cleared decision on July 25, 2011, 145 days after receiving the submission on March 2, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K110592 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2011
Decision Date July 25, 2011
Days to Decision 145 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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