Product code IPY
- Device name
- Orthosis, Lumbo-Sacral
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3490
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K823882 | M-BRACE | Buckman Consultants | 1983-01-17 |
| K823823 | LUMBOSACRAL SUPPORT | Danek Medical, Inc. | 1983-01-14 |
| K812422 | CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS | Surgical Appliance Industries, Inc. | 1981-09-14 |
| K812099 | CASH ORTHOSIS | David Hendricks, C.P.O. | 1981-08-13 |
| K811494 | LUMBO-SACRAL FLEXION ORTHOSIS | Surgical Appliance Industries, Inc. | 1981-06-16 |
| K810554 | LUMBAR FLEXION BRACE | Orthomedics | 1981-03-13 |
| K810556 | SPINAL EXTENSION BRACE | Orthomedics | 1981-03-13 |
| K803033 | CRUSADER HYPEREXTENSION BRACE | Orthomedics | 1980-12-22 |
| K801712 | LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC | Fred Sammons, Inc. | 1980-08-07 |
| K792269 | WRIGHT DOW CORNING SOFTGOODS W/DOW | Dow Corning Wright | 1980-02-05 |
| K791314 | VERTEBRACE SPINAL SUPPORTS | Vertebrace, Inc. | 1979-07-30 |
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|---|---|---|---|
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| 00854682001967 | ThermaZone | INNOVATIVE MEDICAL EQUIPMENT, LLC | 2026-04-24 |
| 00810113683546 | Tailback2-50 CureTech | Manamed, Inc. | 2025-10-03 |
| 00810113683508 | ManaMomma Maternity Back Brace, Custom Label | Manamed, Inc. | 2025-10-03 |
| 00810113683492 | ManaMomma Maternity Back Brace | Manamed, Inc. | 2025-10-03 |
| 07798094540832 | WELLBRACE | PANTYMED S.A. | 2024-01-08 |
| 07798094541051 | WELLBRACE | PANTYMED S.A. | 2024-01-08 |
| 07798094541044 | WELLBRACE | PANTYMED S.A. | 2024-01-08 |
| 07798094541037 | WELLBRACE | PANTYMED S.A. | 2024-01-08 |
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| 07798094540887 | WELLBRACE | PANTYMED S.A. | 2024-01-08 |
| 07798094540894 | WELLBRACE | PANTYMED S.A. | 2024-01-08 |
| 07798094540917 | WELLBRACE | PANTYMED S.A. | 2024-01-08 |
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| 14026704712776 | ARROW | TELEFLEX INCORPORATED | 2020-12-22 |
| 14026704712769 | ARROW | TELEFLEX INCORPORATED | 2020-12-16 |
| 14026704628718 | ARROW | TELEFLEX INCORPORATED | 2018-10-11 |
| 14026704628701 | ARROW | TELEFLEX INCORPORATED | 2018-10-11 |