SYNTHES STERILE DRILL BITS

Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK962913
510k NumberK962913
Device Name:SYNTHES STERILE DRILL BITS
ClassificationInstrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeHWE  
Subsequent Product CodeGFA
Subsequent Product CodeGFF
Subsequent Product CodeHSZ
CFR Regulation Number878.4820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-26
Decision Date1996-11-14
Summary:summary

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