SYNTHECEL DURA REPLACEMENT DEVICES

Dura Substitute

SYNTHES

The following data is part of a premarket notification filed by Synthes with the FDA for Synthecel Dura Replacement Devices.

Pre-market Notification Details

Device IDK113071
510k NumberK113071
Device Name:SYNTHECEL DURA REPLACEMENT DEVICES
ClassificationDura Substitute
Applicant SYNTHES 1301 Goshen Parkway West Chester,  PA  19380
ContactAndrea M Tasker
CorrespondentAndrea M Tasker
SYNTHES 1301 Goshen Parkway West Chester,  PA  19380
Product CodeGXQ  
CFR Regulation Number882.5910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-17
Decision Date2012-01-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H980SC40012001S0 K113071 000
H980SC40005601S0 K113071 000
H980SC40002501S0 K113071 000
H980SC40001901S0 K113071 000
H980SC40000601S0 K113071 000

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