EXTENSION CONTROL KNEE ORTHOSIS
FDA 510(k) clearance K832742 · decided 1983-09-20
Clearance details
- K-number
- K832742
- Device name
- EXTENSION CONTROL KNEE ORTHOSIS
- Applicant
- Orthomedics
- Decision
- Substantially Equivalent
- Date received
- 1983-08-15
- Decision date
- 1983-09-20
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- ITM
- Device class
- 1
- Regulation number
- 890.3475
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- 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 |
|---|---|---|
| POLI-AXIAL KNEE CAGE (K812064) | Generation II Orthotics, Inc. | 1981-08-13 |
| CAST BRWM, FRACTURE (K770900) | Chase Mfg. Co. | 1977-07-21 |
| FRACTURE CAST BRACE, POLY (K770899) | Chase Mfg. Co. | 1977-07-21 |
| IMPROVED KNEE DRESSING (K760573) | Richard'S Medical Equip., Inc. | 1976-10-05 |
Recalls involving this device
No recalls on record reference this clearance.