← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

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

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.

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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