Orthosis, Lumbo-Sacral
FDA product code IPY · Class I (low risk) · 21 CFR 890.3490 · Physical Medicine
11510(k) clearances
0PMA approvals
1recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K823882 | M-BraceIPY · Traditional | Buckman Consultants | 01/17/1983SE |
| K823823 | Lumbosacral SupportIPY · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K812422 | Custom Contour Lumbosacral OrthosisIPY · Traditional | Surgical Appliance Industries, Inc. | 09/14/1981SE |
| K812099 | Cash OrthosisIPY · Traditional | David Hendricks, C.P.O. | 08/13/1981SE |
| K811494 | Lumbo-Sacral Flexion OrthosisIPY · Traditional | Surgical Appliance Industries, Inc. | 06/16/1981SE |
| K810556 | Spinal Extension BraceIPY · Traditional | Orthomedics | 03/13/1981SE |
| K810554 | Lumbar Flexion BraceIPY · Traditional | Orthomedics | 03/13/1981SE |
| K803033 | Crusader Hyperextension BraceIPY · Traditional | Orthomedics | 12/22/1980SE |
| K801712 | Lumbosacral Supports & Thoraco-Lumbo-SacIPY · Traditional | Fred Sammons, Inc. | 08/07/1980SE |
| K792269 | Wright Dow Corning Softgoods W/DowIPY · Traditional | Dow Corning Wright | 02/05/1980SE |
| K791314 | Vertebrace Spinal SupportsIPY · Traditional | Vertebrace, Inc. | 07/30/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1293-2016 Class II | Back Support Suspenders Clip on Black Back Support Suspenders Sew on BlackOssur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar… | Ossur H / F | 02/24/2016Terminated |