SYNTHES BUTTON PLATE

Fastener, Fixation, Nondegradable, Soft Tissue

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK994364
510k NumberK994364
Device Name:SYNTHES BUTTON PLATE
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-27
Decision Date2000-03-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6794828230 K994364 000

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