Hintermann Series H3 Total Ankle Replacement System

FDA Premarket Approval P160036 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

The 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

DeviceHintermann Series H3 Total Ankle Replacement System
Generic NameProsthesis, Ankle, Uncemented, Non-constrained
ApplicantDT MedTech LLC
Date Received2021-02-26
Decision Date2021-03-11
PMAP160036
SupplementS002
Product CodeNTG 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DT MedTech LLC 110 West Road suite 227 towson, MD 21204

Supplemental Filings

Supplement NumberDateSupplement Type
P160036Original Filing
S002 2021-02-26 30-day Notice
S001 2019-07-01 Normal 180 Day Track No User Fee

NIH GUDID Devices

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