Splint, Traction
A traction splint is an orthopedic device used to apply longitudinal traction to a fractured limb, primarily the femur, to reduce pain, minimize soft tissue injury, and maintain alignment prior to or during definitive treatment. It is classified as an FDA Class 1 device under 21 CFR 888.5890, indicating the lowest level of risk and subject only to general controls. Product code HSP falls under the Orthopedic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
Basic Information
- Product Code
- HSP
- Device Class
- FDA class 1
- Regulation Number
- 888.5890
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K770898 | FRACTURE CAST BRACE KIT, PLASTIC | Jul 21, 1977 | Substantially Equivalent | CHASE MFG. CO. |
FEI Numbers
This FDA classification entry is associated with 64 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 64 registration numbers. Click on an entry to view related FDA registrations.