IPY · Orthosis, Lumbo-Sacral
Physical Medicine · 21 CFR 890.3490 · Class 1
Overview
| Product Code | IPY |
|---|---|
| Device Name | Orthosis, Lumbo-Sacral |
| Regulation | 21 CFR 890.3490 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K823882 | M-BRACE | Buckman Consultants | Jan 17, 1983 | SESE |
| K823823 | LUMBOSACRAL SUPPORT | Danek Medical, Inc. | Jan 14, 1983 | SESE |
| K812422 | CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS | Surgical Appliance Industries, Inc. | Sep 14, 1981 | SESE |
| K812099 | CASH ORTHOSIS | David Hendricks, C.P.O. | Aug 13, 1981 | SESE |
| K811494 | LUMBO-SACRAL FLEXION ORTHOSIS | Surgical Appliance Industries, Inc. | Jun 16, 1981 | SESE |
| K810556 | SPINAL EXTENSION BRACE | Orthomedics | Mar 13, 1981 | SESE |
| K810554 | LUMBAR FLEXION BRACE | Orthomedics | Mar 13, 1981 | SESE |
| K803033 | CRUSADER HYPEREXTENSION BRACE | Orthomedics | Dec 22, 1980 | SESE |
| K801712 | LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC | Fred Sammons, Inc. | Aug 7, 1980 | SESE |
| K792269 | WRIGHT DOW CORNING SOFTGOODS W/DOW | Dow Corning Wright | Feb 5, 1980 | SESE |
| K791314 | VERTEBRACE SPINAL SUPPORTS | Vertebrace, Inc. | Jul 30, 1979 | SESE |
Top Applicants
- Orthomedics — 3 clearances
- Surgical Appliance Industries, Inc. — 2 clearances
- Buckman Consultants — 1 clearance
- Danek Medical, Inc. — 1 clearance
- David Hendricks, C.P.O. — 1 clearance
