Product Code: JDT FDA class 1 21 CFR 888.3000

Cap, Bone

Orthopedic

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.

510(k)s
0
FEI Numbers
9
Registration Numbers
9
Unique Applicants
0
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.