The following data is part of a premarket notification filed by Ascension Orthopedics with the FDA for Integra Digifuse Cannulated Intramedullary Fusion System.
| Device ID | K152527 |
| 510k Number | K152527 |
| Device Name: | Integra DigiFuse Cannulated Intramedullary Fusion System |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-03 |
| Decision Date | 2015-10-29 |
| Summary: | summary |