IPY
11 FDA 510(k) clearances · Product code
20 daysmedian time to decision
28 days90th percentile
11clearances measured
FDA profile
- Official device name
- Orthosis, Lumbo-Sacral
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3490
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1994: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| M-BRACE (K823882) | Buckman Consultants | 1983-01-17 |
| LUMBOSACRAL SUPPORT (K823823) | Danek Medical, Inc. | 1983-01-14 |
| 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 |
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Every clearance here is in the API, with alerts when new ones post.