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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceHintermann Series H3 Total Ankle Replacement System
Generic NameProsthesis, ankle, uncemented, non-constrained
ApplicantDt Medtech, LLC
110 W. Rd.
Suite 227
Towson, MD 21204
PMA NumberP160036
Supplement NumberS002
Date Received02/26/2021
Decision Date03/11/2021
Product Code NTG 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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