FDA product code JDT: Cap, Bone

JDT is the FDA product code for cap, bone. It is a Class I device, regulated under 21 CFR 888.3000 and reviewed by the Orthopedic panel. Devices under JDT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Classification

FieldValue
Device nameCap, Bone
Device classClass I
Regulation21 CFR 888.3000
Review panelOR — Orthopedic
Medical specialtyOrthopedic
Premarket route510(k) exempt
ImplantYes

Recalls for JDT devices

openFDA lists no recalls for product code JDT.

Frequently asked questions

What is FDA product code JDT?

JDT is the FDA product code for cap, bone. It is a Class I device, regulated under 21 CFR 888.3000 and reviewed by the Orthopedic panel.

What device class is JDT?

Class I, regulation 21 CFR 888.3000. Typical premarket route: 510(k) exempt.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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