Cleared Traditional

SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES

K093928 · Synthes (Usa) · Orthopedic
Mar 2010
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K093928 is an FDA 510(k) clearance for the SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Synthes (Usa) (19380, US). The FDA issued a Cleared decision on March 29, 2010, 97 days after receiving the submission on December 22, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K093928 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2009
Decision Date March 29, 2010
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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