IPY — Orthosis, Lumbo-Sacral Class I
FDA product code IPY covers "Orthosis, Lumbo-Sacral", a Class I medical device regulated under 21 CFR 890.3490. Submissions are reviewed by the Physical Medicine panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IPY
- Device Class
- Class I
- Regulation Number
- 890.3490
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K823882 | buckman consultants | M-BRACE | January 17, 1983 |
| K823823 | danek medical | LUMBOSACRAL SUPPORT | January 14, 1983 |
| K812422 | surgical appliance industries | CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS | September 14, 1981 |
| K812099 | david hendricks, c.p.o | CASH ORTHOSIS | August 13, 1981 |
| K811494 | surgical appliance industries | LUMBO-SACRAL FLEXION ORTHOSIS | June 16, 1981 |
| K810554 | orthomedics | LUMBAR FLEXION BRACE | March 13, 1981 |
| K810556 | orthomedics | SPINAL EXTENSION BRACE | March 13, 1981 |
| K803033 | orthomedics | CRUSADER HYPEREXTENSION BRACE | December 22, 1980 |
| K801712 | fred sammons | LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC | August 7, 1980 |
| K792269 | dow corning wright | WRIGHT DOW CORNING SOFTGOODS W/DOW | February 5, 1980 |
| K791314 | vertebrace | VERTEBRACE SPINAL SUPPORTS | July 30, 1979 |