SPONGER CABLE SYSTEM, MODIFICATION

Cerclage, Fixation

PIONEER SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Sponger Cable System, Modification.

Pre-market Notification Details

Device IDK935481
510k NumberK935481
Device Name:SPONGER CABLE SYSTEM, MODIFICATION
ClassificationCerclage, Fixation
Applicant PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855
ContactBurns Severson
CorrespondentBurns Severson
PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-23
Decision Date1994-01-26

NIH GUDID Devices

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