ASCENSION NUGRIP CMC IMPLANT

Prosthesis, Wrist, Carpal Trapezium

ASCENSION ORTHOPEDIC

The following data is part of a premarket notification filed by Ascension Orthopedic with the FDA for Ascension Nugrip Cmc Implant.

Pre-market Notification Details

Device IDK112278
510k NumberK112278
Device Name:ASCENSION NUGRIP CMC IMPLANT
ClassificationProsthesis, Wrist, Carpal Trapezium
Applicant ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin,  TX  78754
ContactBradley W Strasser
CorrespondentBradley W Strasser
ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin,  TX  78754
Product CodeKYI  
CFR Regulation Number888.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-09
Decision Date2011-11-04
Summary:summary

NIH GUDID Devices

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