MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER
FDA 510(k) clearance K821695 · decided 1982-07-20
Clearance details
- K-number
- K821695
- Device name
- MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER
- Applicant
- Micro-Aire Surgical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-08
- Decision date
- 1982-07-20
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- HTT
- 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 |
|---|---|---|
| HALL STERILE BUR (K862529) | Hall Surgical, Division of Zimmer, Inc. | 1986-07-15 |
| CARBIDE CUTTING INSTRUMENT/INTRAARTICU (K802598) | The Anspach Effort, Inc. | 1980-11-19 |
| BUR, SURGICAL CARBIDE (K760236) | Cutter Laboratories, Inc. | 1976-07-26 |
Recalls involving this device
No recalls on record reference this clearance.