The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Ankle Fusion Nail System.
| Device ID | K100925 |
| 510k Number | K100925 |
| Device Name: | ASCENSION ANKLE FUSION NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
| Contact | Debbie Stearns |
| Correspondent | Debbie Stearns ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-02 |
| Decision Date | 2010-07-12 |
| Summary: | summary |