Hintermann Series H3 Total Ankle Replacement System

Prosthesis, Ankle, Uncemented, Non-constrained

FDA Premarket Approval P160036

Pre-market Approval Supplement Details

The hintermann series h3 total ankle replacement system is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease (e. G. Rheumatoid arthritis, hemochromatosis, etc. ). The device system is for prescription use.

DeviceHintermann Series H3 Total Ankle Replacement System
Classification NameProsthesis, Ankle, Uncemented, Non-constrained
Generic NameProsthesis, Ankle, Uncemented, Non-constrained
ApplicantDT MedTech LLC
Date Received2016-08-24
Decision Date2019-06-04
PMAP160036
SupplementS
Product CodeNTG
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address DT MedTech LLC 110 West Road suite 227 towson, MA 21204

Supplemental Filings

Supplement NumberDateSupplement Type
P160036Original Filing
S003 2021-09-10 Normal 180 Day Track No User Fee
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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