K093078 is an FDA 510(k) clearance for the UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Bonutti Research, Inc. (Effingham, US). The FDA issued a Cleared decision on June 23, 2010, 266 days after receiving the submission on September 30, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K093078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2009 |
| Decision Date | June 23, 2010 |
| Days to Decision | 266 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC — Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |