Cap, Bone
A Bone Cap is an orthopedic implant used to cover or cap the end of a bone, typically following amputation or resection, to protect the bone end and improve patient comfort. It is classified as FDA Class 1 (lowest risk), subject only to general controls, which include proper labeling, manufacturing quality, and registration. The product code is JDT, regulated under 21 CFR 888.3000, within the Orthopedic medical specialty. Although a lower-risk classification, this device is flagged as an implant because it is placed within the body.
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Basic Information
- Product Code
- JDT
- Device Class
- FDA class 1
- Regulation Number
- 888.3000
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.