510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SFAClass III

Prosthesis, Finger, Semi-Constrained, Metal/Polymer

Unknown
FDA source (opens on fda.gov)

SFA is the FDA product code for Prosthesis, Finger, Semi-Constrained, Metal/Polymer, a class III device type. FDA's definition for this code reads: "A Prosthesis, finger, semi-constrained, metal/polymer, is intended to replace the total first carpometacarpal joint to reduce pain and improve function when the native joint is compromised due to disease such as osteoarthritis". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SFA
Device name
Prosthesis, Finger, Semi-Constrained, Metal/Polymer
FDA definition
A Prosthesis, finger, semi-constrained, metal/polymer, is intended to replace the total first carpometacarpal joint to reduce pain and improve function when the native joint is compromised due to disease such as osteoarthritis.
Device class
Class III
Review panel
Unknown
Submission type
PMA
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