Orthosis, Cervical-Thoracic, Rigid
A rigid cervical-thoracic orthosis is a firm external brace extending from the neck through the upper thoracic spine, used to immobilize and support the cervicothoracic junction following injury or surgery. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IQF, 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
- IQF
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K832741 | JASON CERVICAL ORTHOSIS | Sep 20, 1983 | Substantially Equivalent | Orthomedics |
| K812342 | ZEE EXTRICATION DEVICE | Sep 21, 1981 | Substantially Equivalent | Zee Medical Products Co., Inc. |
| K811297 | CERVICAL SUPPORT | May 27, 1981 | Substantially Equivalent | Orthomedics |
| K810555 | SCOLIOSIS ORTHOTIC SYSTEM | Mar 13, 1981 | Substantially Equivalent | Orthomedics |
| K791350 | POPE AMBULATORY HALO VEST | Aug 03, 1979 | Substantially Equivalent | Hospital Products Co. |
| K781761 | KENDRICK EXTRICATION DEVICE | Oct 27, 1978 | Substantially Equivalent | Medi-Ked, Inc. |
| K780489 | SPINE BOARD | Apr 12, 1978 | Substantially Equivalent | Marullo, Baldwin, Frieden, Gatewood, |
FEI Numbers
This FDA classification entry is associated with 78 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 78 registration numbers. Click on an entry to view related FDA registrations.