PROXIMAL FEMORAL NAIL (PFN) SYSTEM

Pin, Fixation, Threaded

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK970097
510k NumberK970097
Device Name:PROXIMAL FEMORAL NAIL (PFN) SYSTEM
ClassificationPin, Fixation, Threaded
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 CodeJDW  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-13
Decision Date1997-03-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679030101150 K970097 000
H6793570390 K970097 000

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