SURGICAL DRILL BITS
FDA 510(k) clearance K831712 · decided 1983-07-07
Clearance details
- K-number
- K831712
- Device name
- SURGICAL DRILL BITS
- Applicant
- Medical Specialists IN Packaging
- Decision
- Substantially Equivalent
- Date received
- 1983-05-27
- Decision date
- 1983-07-07
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- HTW
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Renovo Life Hard Carbon Coated Drill Bit (K151661) | Renovo Life, LLC | 2016-01-15 |
| AGEE-WRISTJACK PRE-DRILL KIT (K942906) | Hand Biomechanics Lab, Inc. | 1994-12-22 |
| REAMER BIT (K930339) | Neoligaments, Ltd. | 1993-08-06 |
| CANNULATED DRILL BIT (K915692) | W. L. Gore & Associates, Inc. | 1992-01-16 |
| MITEK ANCHOR DRILL (K892903) | Mitek Surgical Products, Inc. | 1989-10-06 |
| 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 |
| UNIVERSALL DRILL GUIDE (K820226) | Ortho Pared Instruments, Inc. | 1982-02-04 |
Recalls involving this device
No recalls on record reference this clearance.