The following data is part of a premarket notification filed by Orthopaedic Innovations, Inc. with the FDA for Practifix External Fixation System.
| Device ID | K960014 |
| 510k Number | K960014 |
| Device Name: | PRACTIFIX EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ORTHOPAEDIC INNOVATIONS, INC. 825 SOUTH 8TH ST. SUITE 700 Minneapolis, MN 55404 |
| Contact | Carolyn M Steele |
| Correspondent | Carolyn M Steele ORTHOPAEDIC INNOVATIONS, INC. 825 SOUTH 8TH ST. SUITE 700 Minneapolis, MN 55404 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-03-18 |
| Summary: | summary |