PMA P240020S005

Device
TOUCH® CMC 1 Prosthesis
Applicant
Keri Medical SA
PMA number
P240020
Supplement
S005
Product code
SFA
Decision date
2026-04-13
Classification
Orthopedic
Generic name
Prosthesis, finger, semi-constrained, metal/polymer
Approval order statement
approval for the addition of new sealing equipment at two existing manufacturing sites.

Current openFDA PMA Record#

Device
TOUCH® CMC 1 Prosthesis
Applicant
Keri Medical SA
PMA number
P240020
Supplement
S005
Product code
SFA
Generic name
Prosthesis, finger, semi-constrained, metal/polymer
Decision date
2026-04-13
Decision code
OK30
Date received
2026-03-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for the addition of new sealing equipment at two existing manufacturing sites.