510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OMXHumanitarian device exemption

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

Unknown
FDA source (opens on fda.gov)

OMX is the FDA product code for High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OMX
Device name
High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis
FDA 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.
Device class
Humanitarian device exemption
Review panel
Unknown
Submission type
FDA code 6
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code