MITEK ANCHOR DRILL
FDA 510(k) clearance K892903 · decided 1989-10-06
Clearance details
- K-number
- K892903
- Device name
- MITEK ANCHOR DRILL
- Applicant
- Mitek Surgical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-20
- Decision date
- 1989-10-06
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- HTW
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Dedham, MA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| REAMER BIT (K930339) | Neoligaments, Ltd. | 1993-08-06 |
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| FEMORAL CEMENT REMOVAL INSTRUMENTS (K870217) | Kenneth J. Hoek, M.D., Inc. | 1987-02-06 |
| GLENOID DRILL (K863147) | Bowen & Company, Inc. | 1986-09-05 |
| DRILL BIT (K841629) | Plastafil, Inc. | 1984-08-27 |
| BONE PLUGGING TOOL (K834229) | Standard Surgical | 1984-01-10 |
| SURGICAL DRILL BITS (K831712) | Medical Specialists IN Packaging | 1983-07-07 |
| UNIVERSALL DRILL GUIDE (K820226) | Ortho Pared Instruments, Inc. | 1982-02-04 |
Recalls involving this device
No recalls on record reference this clearance.