ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM

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 Arthroplasty System.

Pre-market Notification Details

Device IDK062861
510k NumberK062861
Device Name:ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM
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 Received2006-09-25
Decision Date2006-10-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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