SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) [synthes[ Self-drilling Schanz Screw.

Pre-market Notification Details

Device IDK952296
510k NumberK952296
Device Name:SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ 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 Received1995-05-16
Decision Date1995-08-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679SD2945600 K952296 000
H679SD2940080 K952296 000

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