Splint, Clavicle
A clavicle splint is an external immobilization device worn around the shoulders and chest to hold the clavicle in proper alignment during healing from a fracture or dislocation. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IQJ, 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
- IQJ
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K823809 | CLAVICAL STRAP | Jan 14, 1983 | Substantially Equivalent | Danek Medical, Inc. |
| K823661 | CLAVICLE SUPPORT | Dec 30, 1982 | Substantially Equivalent | Warm & Form, Orthopedic Materials |
| K823157 | CLAVICLE SUPPORT | Nov 10, 1982 | Substantially Equivalent | Warm & Form, Orthopedic Materials |
| K760577 | RICHARDS CLAVICLE STRAP | Oct 06, 1976 | Substantially Equivalent | Richard'S Medical Equip., Inc. |
FEI Numbers
This FDA classification entry is associated with 113 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 113 registration numbers. Click on an entry to view related FDA registrations.