SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Locking Proximal Plating (l-ptp) System.

Pre-market Notification Details

Device IDK002361
510k NumberK002361
Device Name:SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactBonnie J Smith
CorrespondentBonnie J Smith
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 Received2000-08-03
Decision Date2000-10-31

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