The following data is part of a premarket notification filed by Bonutti Research, Inc. with the FDA for Unity Ultrasonic System With Plla Anchors.
| Device ID | K093078 |
| 510k Number | K093078 |
| Device Name: | UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS |
| Classification | Screw, Fixation, Bone |
| Applicant | BONUTTI RESEARCH, INC. 2600 SOUTH RANEY P.O. BOX 1367 Effingham, IL 62401 |
| Contact | Patrick G Balsmann |
| Correspondent | Patrick G Balsmann BONUTTI RESEARCH, INC. 2600 SOUTH RANEY P.O. BOX 1367 Effingham, IL 62401 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-30 |
| Decision Date | 2010-06-23 |
| Summary: | summary |