DT MedTech LLC 322515

GUDID B095322515

H2 PE INLAY SIZE 5 - LEFT ‐ 5MM/ANTERIOR

DT MEDTECH, LLC

Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing Ankle prosthesis bearing

• Primary Device ID: B095322515
• NIH Device Record Key: c50130ad-32a3-4773-a034-0ba60c89d9b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DT MedTech LLC
• Version Model Number: 1
• Catalog Number: 322515
• Company DUNS: 080101891
• Company Name: DT MEDTECH, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 410-427-0003
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com
• Phone: 999-999-9999
• Email: quality@dtmedtech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B095322515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171004

FDA Product Code

• HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-20

Devices Manufactured by DT MEDTECH, LLC

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• B095301202 - Hintermann Series H3: 2024-02-28 H3 TIBIAL COMPONENT RIGHT SIZE 2
• B095301203 - Hintermann Series H3: 2024-02-28 H3 TIBIAL COMPONENT RIGHT SIZE 3
• B095301204 - Hintermann Series H3: 2024-02-28 H3 TIBIAL COMPONENT RIGHT SIZE 4
• B095301205 - Hintermann Series H3: 2024-02-28 H3 TIBIAL COMPONENT RIGHT SIZE 5
• B095301206 - Hintermann Series H3: 2024-02-28 H3 TIBIAL COMPONENT RIGHT SIZE 6
• B095300205 - Hintermann Series H3: 2024-02-27 H3 PE INLAY SIZE 2 - 5mm
• B095300206 - Hintermann Series H3: 2024-02-27 H3 PE INLAY SIZE 2 - 6mm