FDA product code OMX

High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis

Unknown·Class f·21 CFR ·Implantable
US regulatory classifications
US Product Code (FDA)
OMX
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US Risk Class (FDA)
Class f
US Regulation (CFR)
21 CFR
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Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient: a) has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction; and b) needs a revision of a failed PIP prosthesis, or has pain, limited motion, or joint subluxation/disloation secondary to damage or destruction of the articular cartilage.

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About this record

High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.