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PMA P160036S002

Device
Hintermann Series H3 Total Ankle Replacement System
Applicant
Dt Medtech, LLC
PMA number
P160036
Supplement
S002
Product code
NTG
Decision date
2021-03-11
Generic name
Prosthesis, ankle, uncemented, non-constrained
Approval order statement
Introduction of a new robotic system at Marle Orthopaedics SAS (approved supplier of DT MedTech). The new robotic system will replace the existing robotic system which is used to manufacture components for the Hintermann Series H3 Total Ankle Replacement System.

Current openFDA PMA Record#

Device
Hintermann Series H3 Total Ankle Replacement System
Applicant
Dt Medtech, LLC
PMA number
P160036
Supplement
S002
Product code
NTG
Generic name
Prosthesis, ankle, uncemented, non-constrained
Decision date
2021-03-11
Decision code
OK30
Date received
2021-02-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of a new robotic system at Marle Orthopaedics SAS (approved supplier of DT MedTech). The new robotic system will replace the existing robotic system which is used to manufacture components for the Hintermann Series H3 Total Ankle Replacement System.