The following data is part of a premarket notification filed by Acute Innovations Llc with the FDA for Acute Bone Screw.
| Device ID | K061206 |
| 510k Number | K061206 |
| Device Name: | ACUTE BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | ACUTE INNOVATIONS LLC 5885 NW CORNELIUS PASS RD. SUITE 200 Hillsboro, OR 97124 |
| Contact | Alyssa Thomas |
| Correspondent | Alyssa Thomas ACUTE INNOVATIONS LLC 5885 NW CORNELIUS PASS RD. SUITE 200 Hillsboro, OR 97124 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-01 |
| Decision Date | 2006-06-19 |
| Summary: | summary |