Joint, Hip, External Limb Component
A hip joint external limb component is a prosthetic joint unit providing hip articulation for patients with hip disarticulation or hemipelvectomy amputations, enabling sitting and ambulation in an external prosthesis. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ISL, 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
- ISL
- Device Class
- FDA class 1
- Regulation Number
- 890.3420
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.