The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Ultimax Ankle Fusion Rod System.
| Device ID | K991790 |
| 510k Number | K991790 |
| Device Name: | ULTIMAX ANKLE FUSION ROD SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Debbie De Los Santos |
| Correspondent | Debbie De Los Santos ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-26 |
| Decision Date | 1999-08-06 |
| Summary: | summary |