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Data / Medical devices / United States / DT Medtech LLC

DT Medtech LLC: FDA-registered device maker in McMinnville, TN, United States, 1 PMA approval

DT Medtech LLC is registered with the FDA (registration 3012104767) in McMinnville, TN, United States. It lists 13 device types. The FDA files 1 PMA approval under its listings, the newest dated June 4, 2019. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch DT Medtech LLC
FDA registration number
3012104767
Address
111 Moffitt Street, McMinnville, TN, United States, 37110
Owner or operator
DT MedTech LLC (10056316)
Roles
Specification developer
First device listed
July 18, 2019
Registered through
2027
Brand names listed
Hintermann Series H3 Total Ankle Replacement System, Hintermann Series Instruments, Saw Blade

Devices it lists

DeviceProduct codeClassRoleSource
Bit, DrillHTW1Specification developeraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Specification developeraccessdata.fda.gov
Gauge, DepthHTJ1Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Specification developeraccessdata.fda.gov
ImpactorHWA1Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Specification developeraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Specification developeraccessdata.fda.gov
Prosthesis, Ankle, Uncemented, Non-ConstrainedNTG3Specification developeraccessdata.fda.gov
ReamerHTO1Specification developeraccessdata.fda.gov
RetractorGAD1Specification developeraccessdata.fda.gov
ScrewdriverHXX1Specification developeraccessdata.fda.gov
Starter, Bone ScrewHWD1Specification developeraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
June 4, 2019P160036Hintermann Series H3 Total Ankle Replacement SystemNTG6July 31, 2026accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
March 24, 202698987Class IIOngoingHintermann Series Talar Implant, Left, Size 2 REF 302112Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device.accessdata.fda.gov
September 25, 201881293Class IITerminatedDT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.Incorrect package labeling identifying the deviceaccessdata.fda.gov

Compare with other makers

Updated July 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.