SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 7.3 Mm Cannulated Slipped Capital Femoral Epiphysis Screws (scfe).

Pre-market Notification Details

Device IDK092909
510k NumberK092909
Device Name:SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE)
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 Received2009-09-22
Decision Date2010-01-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679022076370 K092909 000
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H679022076000 K092909 000

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