Cleared Special

SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

K111667 · Synthes (Usa) · Orthopedic
Dec 2011
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K111667 is an FDA 510(k) clearance for the SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS, a Nail, Fixation, Bone (Class II — Special Controls, product code JDS), submitted by Synthes (Usa) (19380, US). The FDA issued a Cleared decision on December 5, 2011, 174 days after receiving the submission on June 14, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K111667 FDA.gov
FDA Decision Cleared SESE
Date Received June 14, 2011
Decision Date December 05, 2011
Days to Decision 174 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDS — Nail, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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