The following data is part of a premarket notification filed by Acute Innovations Llc with the FDA for Acute Innovations Sternal Fixation System.
| Device ID | K101170 |
| 510k Number | K101170 |
| Device Name: | ACUTE INNOVATIONS STERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ACUTE INNOVATIONS LLC 21421 NW JACOBSON RD. SUITE 700 Hillsboro, OR 97124 |
| Contact | Mariah Knight |
| Correspondent | Mariah Knight ACUTE INNOVATIONS LLC 21421 NW JACOBSON RD. SUITE 700 Hillsboro, OR 97124 |
| Product Code | KTT |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDQ |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-26 |
| Decision Date | 2010-09-17 |
| Summary: | summary |