Prosthesis, Thigh Socket, External Component
A thigh socket external prosthetic component is the custom-fabricated or modular socket that interfaces with a transfemoral (above-knee) amputee's residual limb, forming the critical structural and suspension link between the patient and the prosthetic leg. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ISS, regulated under 21 CFR 890.3420, within the Physical Medicine medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- ISS
- Device Class
- FDA class 1
- Regulation Number
- 890.3420
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K802911 | A/K SOCKET | Dec 17, 1980 | Substantially Equivalent | Orthomedics |
FEI Numbers
This FDA classification entry is associated with 45 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 45 registration numbers. Click on an entry to view related FDA registrations.