SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION

Pin, Fixation, Smooth

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Proximal Femoral Nail(pfn) System Modification.

Pre-market Notification Details

Device IDK973240
510k NumberK973240
Device Name:SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION
ClassificationPin, Fixation, Smooth
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-28
Decision Date1997-11-20
Summary:summary

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