SYNTHES CALCANEAL PLATE

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Calcaneal Plate.

Pre-market Notification Details

Device IDK020401
510k NumberK020401
Device Name:SYNTHES CALCANEAL PLATE
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactMatthew M Hull
CorrespondentMatthew M Hull
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-07
Decision Date2002-05-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679SD2410030 K020401 000
H679SD2410020 K020401 000

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