The following data is part of a premarket notification filed by Bonutti Research, Inc. with the FDA for Unity Beta Plla System.
| Device ID | K090175 |
| 510k Number | K090175 |
| Device Name: | UNITY BETA PLLA SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | BONUTTI RESEARCH, INC. 2600 SOUTH RANEY P.O. BOX 1367 Effingham, IL 62401 |
| Contact | Patrick Balsmann |
| Correspondent | Patrick 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-23 |
| Decision Date | 2009-09-10 |
| Summary: | summary |