TRUNCAL ORTHOSIS
FDA 510(k) clearance K821682 · decided 1982-06-24
Clearance details
- K-number
- K821682
- Device name
- TRUNCAL ORTHOSIS
- Applicant
- Surgical Appliance Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-08
- Decision date
- 1982-06-24
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- IQE
- Device class
- 1
- Regulation number
- 890.3490
- 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 |
|---|---|---|
| OBUS FORME ORTHOPEDIC BRACE, UPRIGHT (K820051) | Obus Forme, Ltd. | 1982-01-29 |
| PROSANA BELT (K812719) | Bandwagon, Inc. | 1981-10-06 |
| TRUNCAL ORTHOSIS (K810450) | Fred Sammons, Inc. | 1981-03-04 |
Recalls involving this device
No recalls on record reference this clearance.