HALL STERILE BUR
FDA 510(k) clearance K862529 · decided 1986-07-15
Clearance details
- K-number
- K862529
- Device name
- HALL STERILE BUR
- Applicant
- Hall Surgical, Division of Zimmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-02
- Decision date
- 1986-07-15
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- HTT
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- `Anta Barbara, CA, 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 |
|---|---|---|
| MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER (K821695) | Micro-Aire Surgical Instruments, Inc. | 1982-07-20 |
| 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.