Panels › Physical Medicine › Product code IPY · Class 1
Orthosis, Lumbo-Sacral
Regulation 890.3490
0510(k)s in 12 months (11 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in IPY
| Company | 510(k)s | Recalls |
|---|---|---|
| Orthomedics | 3 | 0 |
| Surgical Appliance Industries, Inc. | 2 | 0 |
| Buckman Consultants | 1 | 0 |
| Danek Medical, Inc. | 1 | 0 |
| David Hendricks, C.P.O. | 1 | 0 |
| Dow Corning Wright | 1 | 0 |
| Fred Sammons, Inc. | 1 | 0 |
| Ossur H / F | 0 | 1 |
| Vertebrace, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 17, 1983 | K823882 | M-BRACE Buckman Consultants | IPY |
| Jan 14, 1983 | K823823 | LUMBOSACRAL SUPPORT Danek Medical, Inc. | IPY |
| Sep 14, 1981 | K812422 | CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS Surgical Appliance Industries, Inc. | IPY |
| Aug 13, 1981 | K812099 | CASH ORTHOSIS David Hendricks, C.P.O. | IPY |
| Jun 16, 1981 | K811494 | LUMBO-SACRAL FLEXION ORTHOSIS Surgical Appliance Industries, Inc. | IPY |
| Mar 13, 1981 | K810556 | SPINAL EXTENSION BRACE Orthomedics | IPY |
| Mar 13, 1981 | K810554 | LUMBAR FLEXION BRACE Orthomedics | IPY |
| Dec 22, 1980 | K803033 | CRUSADER HYPEREXTENSION BRACE Orthomedics | IPY |
| Aug 7, 1980 | K801712 | LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC Fred Sammons, Inc. | IPY |
| Feb 5, 1980 | K792269 | WRIGHT DOW CORNING SOFTGOODS W/DOW Dow Corning Wright | IPY |
| Jul 30, 1979 | K791314 | VERTEBRACE SPINAL SUPPORTS Vertebrace, Inc. | IPY |
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