SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 2.7 Mm Lc-dcp, 3.5 Mm Profile.

Pre-market Notification Details

Device IDK011170
510k NumberK011170
Device Name:SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactThomas M Maguire
CorrespondentThomas M Maguire
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-17
Decision Date2001-07-05

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