The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Sterile Modular Drill Bit.
| Device ID | K960720 |
| 510k Number | K960720 |
| Device Name: | EXACTECH STERILE MODULAR DRILL BIT |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | EXACTECH, INC. 4613 NW 6TH ST. Gainesville, FL 32609 |
| Contact | Martha C Miller |
| Correspondent | Martha C Miller EXACTECH, INC. 4613 NW 6TH ST. Gainesville, FL 32609 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-22 |
| Decision Date | 1996-04-23 |
| Summary: | summary |