LUMBOSACRAL SUPPORT
FDA 510(k) clearance K823823 · decided 1983-01-14
Clearance details
- K-number
- K823823
- Device name
- LUMBOSACRAL SUPPORT
- Applicant
- Danek Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-17
- Decision date
- 1983-01-14
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- IPY
- Device class
- 1
- Regulation number
- 890.3490
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Walker, MI, 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 |
|---|---|---|
| M-BRACE (K823882) | Buckman Consultants | 1983-01-17 |
| CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS (K812422) | Surgical Appliance Industries, Inc. | 1981-09-14 |
| CASH ORTHOSIS (K812099) | David Hendricks, C.P.O. | 1981-08-13 |
| LUMBO-SACRAL FLEXION ORTHOSIS (K811494) | Surgical Appliance Industries, Inc. | 1981-06-16 |
| LUMBAR FLEXION BRACE (K810554) | Orthomedics | 1981-03-13 |
| SPINAL EXTENSION BRACE (K810556) | Orthomedics | 1981-03-13 |
| CRUSADER HYPEREXTENSION BRACE (K803033) | Orthomedics | 1980-12-22 |
| LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC (K801712) | Fred Sammons, Inc. | 1980-08-07 |
| WRIGHT DOW CORNING SOFTGOODS W/DOW (K792269) | Dow Corning Wright | 1980-02-05 |
| VERTEBRACE SPINAL SUPPORTS (K791314) | Vertebrace, Inc. | 1979-07-30 |
Recalls involving this device
No recalls on record reference this clearance.