ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

ASCENSION ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Humeral Resurfacing Arthoplasty (hra) System Tps/ha.

Pre-market Notification Details

Device IDK071064
510k NumberK071064
Device Name:ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin,  TX  78754 -3832
ContactGlen Neally
CorrespondentGlen Neally
ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin,  TX  78754 -3832
Product CodeHSD  
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-16
Decision Date2007-06-22
Summary:summary

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