The following data is part of a premarket notification filed by Ascension Orthopedic with the FDA for Integra External Fixation System.
| Device ID | K140463 |
| 510k Number | K140463 |
| Device Name: | INTEGRA EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ASCENSION ORTHOPEDIC 560 W. GOLF COURSE ROAD Providence, UT 84332 |
| Contact | Steve Brown |
| Correspondent | Steve Brown ASCENSION ORTHOPEDIC 560 W. GOLF COURSE ROAD Providence, UT 84332 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-24 |
| Decision Date | 2014-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M268XFIX4RCKRIMP1 | K140463 | 000 |
| 10381780125679 | K140463 | 000 |
| 10381780125426 | K140463 | 000 |
| 10381780125419 | K140463 | 000 |
| M268XFIX5RINGIMP1 | K140463 | 000 |
| M268XFIX2RODSIMP1 | K140463 | 000 |
| M268XFIX1BOLTIMP1 | K140463 | 000 |
| 10381780125402 | K140463 | 000 |