TI. ALLOY 2.0 MM CORTEX SCREW

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Ti. Alloy 2.0 Mm Cortex Screw.

Pre-market Notification Details

Device IDK952272
510k NumberK952272
Device Name:TI. ALLOY 2.0 MM CORTEX SCREW
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 (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-15
Decision Date1995-07-31
Summary:summary

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