Orthosis, Truncal/Orthosis, Limb
The Truncal/Limb Orthosis is a physical medicine device encompassing external supportive braces or splints applied to the trunk or limbs to provide support, correct alignment, restrict motion, or assist function in patients with musculoskeletal or neurological conditions. Classified as FDA Class 1 under 21 CFR 890.3490, it is GMP-exempt and 510(k)-exempt, subject only to general controls. The product code is MRI.
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Basic Information
- Product Code
- MRI
- 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 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K973031 | STABILIZER SOFT TISSUE ANCHOR 5MM MODEL TA1005, ANCHOR INSERTER/SUTURE ORGANIZER 5MM AI1005, STABILIZER DRILL 5MM NONSTE | Nov 03, 1997 | Substantially Equivalent | R. Thomas Grotz, M.D., Inc. |
| K923880 | ORLAU SWIVEL WALKER | Sep 30, 1996 | Substantially Equivalent | Mopac, Ltd. |
FEI Numbers
This FDA classification entry is associated with 159 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 159 registration numbers. Click on an entry to view related FDA registrations.