The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Bone Screw.
| Device ID | K896601 |
| 510k Number | K896601 |
| Device Name: | EXACTECH BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Contact | William Petty |
| Correspondent | William Petty EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-21 |
| Decision Date | 1989-12-06 |