Cleared Traditional

DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM

K141527 · Synthes (Usa) · Orthopedic
Mar 2015
Decision
294d
Days
Class 2
Risk

About This 510(k) Submission

K141527 is an FDA 510(k) clearance for the DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM, 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 30, 2015, 294 days after receiving the submission on June 9, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K141527 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 2014
Decision Date March 30, 2015
Days to Decision 294 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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