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.
Device ID | K102549 |
510k Number | K102549 |
Device Name: | THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY |
Classification | Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
Applicant | ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
Contact | Susan Walton |
Correspondent | Susan Walton ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
Product Code | LZJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-07 |
Decision Date | 2010-12-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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 |