FDA product code SFA: Prosthesis, Finger, Semi-Constrained, Metal/Polymer
SFA is the FDA product code for prosthesis, finger, semi-constrained, metal/polymer. It is a Class III device, reviewed by the Orthopedic panel. Devices under SFA reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Finger, Semi-Constrained, Metal/Polymer |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for SFA devices
openFDA lists no recalls for product code SFA.
Frequently asked questions
What is FDA product code SFA?
SFA is the FDA product code for prosthesis, finger, semi-constrained, metal/polymer. It is a Class III device, reviewed by the Orthopedic panel.
What device class is SFA?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SFA
- Run a recall and safety report across every SFA manufacturer
- Watch product code SFA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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