Orthosis, Lumbo-Sacral
A lumbo-sacral orthosis is an external brace encompassing the lumbar spine and sacral region, used to provide support, limit motion, and relieve pain in the lower back. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IPY, regulated under 21 CFR 890.3490, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- IPY
- Device Class
- FDA class 1
- Regulation Number
- 890.3490
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K823882 | M-BRACE | Jan 17, 1983 | Substantially Equivalent | Buckman Consultants |
| K823823 | LUMBOSACRAL SUPPORT | Jan 14, 1983 | Substantially Equivalent | Danek Medical, Inc. |
| K812422 | CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS | Sep 14, 1981 | Substantially Equivalent | Surgical Appliance Industries, Inc. |
| K812099 | CASH ORTHOSIS | Aug 13, 1981 | Substantially Equivalent | David Hendricks, C.P.O. |
| K811494 | LUMBO-SACRAL FLEXION ORTHOSIS | Jun 16, 1981 | Substantially Equivalent | Surgical Appliance Industries, Inc. |
| K810556 | SPINAL EXTENSION BRACE | Mar 13, 1981 | Substantially Equivalent | Orthomedics |
| K810554 | LUMBAR FLEXION BRACE | Mar 13, 1981 | Substantially Equivalent | Orthomedics |
| K803033 | CRUSADER HYPEREXTENSION BRACE | Dec 22, 1980 | Substantially Equivalent | Orthomedics |
| K801712 | LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC | Aug 07, 1980 | Substantially Equivalent | Fred Sammons, Inc. |
| K792269 | WRIGHT DOW CORNING SOFTGOODS W/DOW | Feb 05, 1980 | Substantially Equivalent | Dow Corning Wright |
| K791314 | VERTEBRACE SPINAL SUPPORTS | Jul 30, 1979 | Substantially Equivalent | Vertebrace, Inc. |
FEI Numbers
This FDA classification entry is associated with 184 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 184 registration numbers. Click on an entry to view related FDA registrations.