SHORTENING OSTEOTOMY GUIDE
FDA 510(k) clearance K861576 · decided 1986-05-12
Clearance details
- K-number
- K861576
- Device name
- SHORTENING OSTEOTOMY GUIDE
- Applicant
- Osteotomy Guide Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-28
- Decision date
- 1986-05-12
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- HTH
- Device class
- 1
- Regulation number
- 888.4600
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mesa, AZ, 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 |
|---|---|---|
| REESE OSTEOTOMY GUIDE SYS (K841470) | Osteotomy Guide Co. | 1984-05-23 |
| ORTHO-LEVEL (K822305) | Frontier Products | 1982-08-20 |
Recalls involving this device
No recalls on record reference this clearance.