THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY

Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained

ASCENSION ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for The Ascension Movement Great Toe System Total Arthroplasty.

Pre-market Notification Details

Device IDK102549
510k NumberK102549
Device Name:THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
ClassificationProsthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained
Applicant ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin,  TX  78754 -3832
ContactSusan Walton
CorrespondentSusan Walton
ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin,  TX  78754 -3832
Product CodeLZJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-07
Decision Date2010-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780119920 K102549 000
00885556828250 K102549 000
00885556828281 K102549 000
00885556828311 K102549 000
00885556828410 K102549 000
00885556828441 K102549 000
00885556828472 K102549 000
00885556828502 K102549 000
10381780119890 K102549 000
10381780119906 K102549 000
10381780119913 K102549 000
00885556828229 K102549 000

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