Cleared Traditional

SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM

K102656 · Synthes (Usa) · Dental
Dec 2010
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K102656 is an FDA 510(k) clearance for the SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Synthes (Usa) (19380, US). The FDA issued a Cleared decision on December 20, 2010, 96 days after receiving the submission on September 15, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K102656 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2010
Decision Date December 20, 2010
Days to Decision 96 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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