SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 4.5 Mm And 6.5 Mm Headless Compression Screws.

Pre-market Notification Details

Device IDK080943
510k NumberK080943
Device Name:SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
ClassificationScrew, Fixation, Bone
Applicant SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-03
Decision Date2008-04-23
Summary:summary

NIH GUDID Devices

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