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 |