The following data is part of a premarket notification filed by Bonutti Research, Inc. with the FDA for Unity Beta Anchor System.
| Device ID | K082906 |
| 510k Number | K082906 |
| Device Name: | UNITY BETA ANCHOR SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | BONUTTI RESEARCH, INC. P.O. BOX 1367 Effingham, IL 62401 |
| Contact | Patrick G Balsmann |
| Correspondent | Patrick G Balsmann BONUTTI RESEARCH, INC. 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 | 2008-09-30 |
| Decision Date | 2008-10-30 |
| Summary: | summary |