ORTHO-LEVEL
FDA 510(k) clearance K822305 · decided 1982-08-20
Clearance details
- K-number
- K822305
- Device name
- ORTHO-LEVEL
- Applicant
- Frontier Products
- Decision
- Substantially Equivalent
- Date received
- 1982-07-27
- Decision date
- 1982-08-20
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- HTH
- Device class
- 1
- Regulation number
- 888.4600
- 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 |
|---|---|---|
| SHORTENING OSTEOTOMY GUIDE (K861576) | Osteotomy Guide Co. | 1986-05-12 |
| REESE OSTEOTOMY GUIDE SYS (K841470) | Osteotomy Guide Co. | 1984-05-23 |
Recalls involving this device
No recalls on record reference this clearance.