MODIFICATION TO SYNTHES CRANIAL PLATES

Plate, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To Synthes Cranial Plates.

Pre-market Notification Details

Device IDK042987
510k NumberK042987
Device Name:MODIFICATION TO SYNTHES CRANIAL PLATES
ClassificationPlate, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactLisa M Boyle
CorrespondentLisa M Boyle
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-10-29
Decision Date2004-11-23
Summary:summary

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