MRI · Orthosis, Truncal/Orthosis, Limb
Physical Medicine · 21 CFR 890.3490 · Class 1
Overview
| Product Code | MRI |
|---|---|
| Device Name | Orthosis, Truncal/Orthosis, Limb |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973031 | STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE | R. Thomas Grotz, M.D., Inc. | Nov 3, 1997 | SESE |
| K923880 | ORLAU SWIVEL WALKER | Mopac, Ltd. | Sep 30, 1996 | SESE |
Top Applicants
- Mopac, Ltd. — 1 clearance
- R. Thomas Grotz, M.D., Inc. — 1 clearance
