SPL CRIMP SYSTEM

Cerclage, Fixation

PIONEER SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Spl Crimp System.

Pre-market Notification Details

Device IDK002110
510k NumberK002110
Device Name:SPL CRIMP SYSTEM
ClassificationCerclage, Fixation
Applicant PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855 -0627
ContactAmy H Mommaerts
CorrespondentAmy H Mommaerts
PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855 -0627
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-12
Decision Date2000-10-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98149199201S0 K002110 000
H98149199101S0 K002110 000
H98129199201S0 K002110 000
H98129199101S0 K002110 000

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