The following data is part of a premarket notification filed by Apogee Medical Products, Inc. with the FDA for Bonutti Anchor.
| Device ID | K934183 |
| 510k Number | K934183 |
| Device Name: | BONUTTI ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | APOGEE MEDICAL PRODUCTS, INC. PO BOX 1387 Effingham, IL 62401 |
| Contact | Bryan G Miller |
| Correspondent | Bryan G Miller APOGEE MEDICAL PRODUCTS, INC. PO BOX 1387 Effingham, IL 62401 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-26 |
| Decision Date | 1996-04-03 |