The following data is part of a premarket notification filed by Ascension Orthopedics with the FDA for Integra External Fixation System.
| Device ID | K160830 |
| 510k Number | K160830 |
| Device Name: | Integra External Fixation System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Ascension Orthopedics 8700 Cameron Road, Suite 100 Austin, TX 78754 |
| Contact | Jayana Kenana |
| Correspondent | Jayana Kenana Integra LifeSciences 311 Enterprise Drive Plainsboro, NJ 08536 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-25 |
| Decision Date | 2016-07-06 |
| Summary: | summary |