DT MedTech LLC 322515

GUDID B095322515

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

DT MEDTECH, LLC

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

• B095300105 - Hintermann Series H3: 2025-09-05 H3 PE INLAY SIZE 1 - 5mm
• B095300106 - Hintermann Series H3: 2025-09-05 H3 PE INLAY SIZE 1 - 6mm
• B095300107 - Hintermann Series H3: 2025-09-05 H3 PE INLAY SIZE 1 - 7mm
• B095300109 - Hintermann Series H3: 2025-09-05 H3 PE INLAY SIZE 1 - 9mm
• B095300209 - Hintermann Series H3: 2025-09-05 H3 PE INLAY SIZE 2 - 9mm
• B095300405 - Hintermann Series H3: 2025-09-05 H3 PE INLAY SIZE 4 - 5mm
• B095301111 - Hintermann Series H3: 2025-09-05 TALAR COMPONENT RIGHT SIZE 1
• B095301112 - Hintermann Series H3: 2025-09-05 TALAR COMPONENT RIGHT SIZE 2