PMA P160036S004

Device: Hintermann Series H3 Total Ankle Replacement System
Applicant: Dt Medtech, LLC
PMA number: P160036
Supplement: S004
Product code: NTG
Decision date: 2023-11-06
Classification: Orthopedic
Generic name: Prosthesis, ankle, uncemented, non-constrained
Approval order statement: Approval to introduce patient specific instrumentation (i.e., OPTIX Patient Specific Instruments (PSI)) to 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: S004
Product code: NTG
Generic name: Prosthesis, ankle, uncemented, non-constrained
Decision date: 2023-11-06
Decision code: APPR
Date received: 2023-05-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to introduce patient specific instrumentation (i.e., OPTIX Patient Specific Instruments (PSI)) to the Hintermann Series H3 Total Ankle Replacement System.