SFA · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
SFA
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
OR
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.