CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD

Plate, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Condylar Prosthesis Of Mandible W/head.

Pre-market Notification Details

Device IDK840955
510k NumberK840955
Device Name:CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD
ClassificationPlate, Bone
Applicant SYNTHES (USA) 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-03-05
Decision Date1984-06-19

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