SYNTHES STERILE 4.5 MM CANNULATED SCREWS

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sterile 4.5 Mm Cannulated Screws.

Pre-market Notification Details

Device IDK963172
510k NumberK963172
Device Name:SYNTHES STERILE 4.5 MM CANNULATED SCREWS
ClassificationScrew, Fixation, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-14
Decision Date1996-11-08
Summary:summary

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