510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DT MedTech, LLC

McMinnville, TN, US

DT MEDTECH LLC appears in FDA device records in McMinnville, TN. FDA records list one 510(k) clearance, 7 PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
7
Recall records
3
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for DT MedTech, LLC in 2017.

Clearances by year, as a table
510(k) clearance decisions for DT MedTech, LLC, by decision year
YearClearances
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K171004Hintermann Series H2 Total Ankle SystemHSNSubstantially Equivalent

Registered establishments

FDA registered establishments for DT MedTech, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30121047673012104767DT MEDTECH LLC111 Moffitt Street, McMinnville, TN 37110 US2026and 3 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2399-2026Hintermann 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.Class IIOpen, Classified
Z-0403-2019DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.Incorrect package labeling identifying the deviceClass IITerminated
Z-0402-2019DT 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 deviceClass IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain