Hintermann Series H2 321319

GUDID B095321319

H2 PE INLAY SIZE 3 - RIGHT ‐ 9MM/ANTERIOR

DT MEDTECH, LLC

Ankle prosthesis bearing

• Primary Device ID: B095321319
• NIH Device Record Key: 69f99a39-dc30-41e0-8a0f-e924f728375f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hintermann Series H2
• Version Model Number: 1
• Catalog Number: 321319
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B095321319 [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: 2018-03-16

On-Brand Devices [Hintermann Series H2]

• B095422836: H2 TIBIAL TRAY SIZE 6 - LEFT (12MM)
• B095422835: H2 TIBIAL TRAY SIZE 5 - LEFT (12MM)
• B095422834: H2 TIBIAL TRAY SIZE 4 - LEFT (12MM)
• B095422833: H2 TIBIAL TRAY SIZE 3 - LEFT (12MM)
• B095422832: H2 TIBIAL TRAY SIZE 2 - LEFT (12MM)
• B095422826: H2 TIBIAL TRAY SIZE 6 - LEFT (9.5MM)
• B095422825: H2 TIBIAL TRAY SIZE 5 - LEFT (9.5MM)
• B095422824: H2 TIBIAL TRAY SIZE 4 - LEFT (9.5MM)
• B095422823: H2 TIBIAL TRAY SIZE 3 - LEFT (9.5MM)
• B095422822: H2 TIBIAL TRAY SIZE 2 - LEFT (9.5MM)
• B095422806: H2 TIBIAL TRAY SIZE 6 - LEFT (7MM)
• B095422805: H2 TIBIAL TRAY SIZE 5 - LEFT (7MM)
• B095422804: H2 TIBIAL TRAY SIZE 4 - LEFT (7MM)
• B095422803: H2 TIBIAL TRAY SIZE 3 - LEFT (7MM)
• B095422802: H2 TIBIAL TRAY SIZE 2 - LEFT (7MM)
• B095421836: H2 TIBIAL TRAY SIZE 6 - RIGHT (12MM)
• B095421835: H2 TIBIAL TRAY SIZE 5 - RIGHT (12MM)
• B095421834: H2 TIBIAL TRAY SIZE 4 - RIGHT (12MM)
• B095421833: H2 TIBIAL TRAY SIZE 3 - RIGHT (12MM)
• B095421832: H2 TIBIAL TRAY SIZE 2 - RIGHT (12MM)
• B095421826: H2 TIBIAL TRAY SIZE 6 - RIGHT (9.5MM)
• B095421825: H2 TIBIAL TRAY SIZE 5 - RIGHT (9.5MM)
• B095421824: H2 TIBIAL TRAY SIZE 4 - RIGHT (9.5MM)
• B095421823: H2 TIBIAL TRAY SIZE 3 - RIGHT (9.5MM)
• B095421822: H2 TIBIAL TRAY SIZE 2 - RIGHT (9.5MM)
• B095421806: H2 TIBIAL TRAY SIZE 6 - RIGHT (7MM)
• B095421805: H2 TIBIAL TRAY SIZE 5 - RIGHT (7MM)
• B095421804: H2 TIBIAL TRAY SIZE 4 - RIGHT (7MM)
• B095421803: H2 TIBIAL TRAY SIZE 3 - RIGHT (7MM)
• B095421802: H2 TIBIAL TRAY SIZE 2 - RIGHT (7MM)
• B095402125: H2 FLAT CUT TALAR COMPONENT LEFT - SIZE 5
• B095402124: H2 FLAT CUT TALAR COMPONENT LEFT - SIZE 4
• B095402123: H2 FLAT CUT TALAR COMPONENT LEFT - SIZE 3
• B095402122: H2 FLAT CUT TALAR COMPONENT LEFT - SIZE 2
• B095402121: H2 FLAT CUT TALAR COMPONENT LEFT - SIZE 1
• B095402116: H2 TALAR COMPONENT LEFT - SIZE 6
• B095402115: H2 TALAR COMPONENT LEFT - SIZE 5
• B095402114: H2 TALAR COMPONENT LEFT - SIZE 4
• B095402113: H2 TALAR COMPONENT LEFT - SIZE 3
• B095402112: H2 TALAR COMPONENT LEFT - SIZE 2
• B095402111: H2 TALAR COMPONENT LEFT - SIZE 1
• B095401125: 1
• B095401124: H2 FLAT CUT TALAR COMPONENT RIGHT - SIZE 4
• B095401123: H2 FLAT CUT TALAR COMPONENT RIGHT - SIZE 3
• B095401122: H2 FLAT CUT TALAR COMPONENT RIGHT - SIZE 2
• B095401121: H2 FLAT CUT TALAR COMPONENT RIGHT - SIZE 1
• B095401116: H2 TALAR COMPONENT RIGHT - SIZE 6
• B095401115: H2 TALAR COMPONENT RIGHT - SIZE 5
• B095401114: H2 TALAR COMPONENT RIGHT - SIZE 4
• B095401113: H2 TALAR COMPONENT RIGHT - SIZE 3