Hintermann Series H3 302205

GUDID B095302205

H3 TIBIAL COMPONENT LEFT SIZE 5

Dt Medtech, LLC

Coated ankle tibia prosthesis

• Primary Device ID: B095302205
• NIH Device Record Key: 86f731e3-7c1d-4daf-b0d0-430d50b9ac45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hintermann Series H3
• Version Model Number: 1
• Catalog Number: 302205
• Company DUNS: 080101891
• Company Name: Dt Medtech, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• 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	B095302205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160036

FDA Product Code

• NTG: Prosthesis, Ankle, Uncemented, Non-Constrained

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-27
• Device Publish Date: 2019-08-19

On-Brand Devices [Hintermann Series H3]

• B0953302206: H3 TIBIAL COMPONENT LEFT SIZE 6
• B0953302205: H3 TIBIAL COMPONENT LEFT SIZE 5
• B0953302204: H3 TIBIAL COMPONENT LEFT SIZE 4
• B0953302203: H3 TIBIAL COMPONENT LEFT SIZE 3
• B0953302202: H3 TIBIAL COMPONENT LEFT SIZE 2
• B0953302201: H3 TIBIAL COMPONENT LEFT SIZE 1
• B0953302125: FC TALAR COMPONENT LEFT SIZE 5
• B0953302124: FC TALAR COMPONENT LEFT SIZE 4
• B0953302123: FC TALAR COMPONENT LEFT SIZE 3
• B0953302122: FC TALAR COMPONENT LEFT SIZE 2
• B0953302121: FC TALAR COMPONENT LEFT SIZE 1
• B0953302116: TALAR COMPONENT LEFT SIZE 6
• B0953302115: TALAR COMPONENT LEFT SIZE 5
• B0953302114: TALAR COMPONENT LEFT SIZE 4
• B0953302113: TALAR COMPONENT LEFT SIZE 3
• B0953302112: TALAR COMPONENT LEFT SIZE 2
• B0953302111: TALAR COMPONENT LEFT SIZE 1
• B0953301125: FC TALAR COMPONENT RIGHT SIZE 5
• B0953301124: FC TALAR COMPONENT RIGHT SIZE 4
• B0953301123: FC TALAR COMPONENT RIGHT SIZE 3
• B0953301122: FC TALAR COMPONENT RIGHT SIZE 2
• B0953301121: FC TALAR COMPONENT RIGHT SIZE 1
• B0953301116: TALAR COMPONENT RIGHT SIZE 6
• B0953301115: TALAR COMPONENT RIGHT SIZE 5
• B0953301114: TALAR COMPONENT RIGHT SIZE 4
• B0953301113: TALAR COMPONENT RIGHT SIZE 3
• B0953301112: TALAR COMPONENT RIGHT SIZE 2
• B0953301111: TALAR COMPONENT RIGHT SIZE 1
• B0953300609: H3 PE INLAY SIZE 6- 9mm
• B0953300607: H3 PE INLAY SIZE 6- 7mm
• B0953300606: H3 PE INLAY SIZE 6- 6mm
• B0953300605: H3 PE INLAY SIZE 6- 5mm
• B0953300509: H3 PE INLAY SIZE 5- 9mm
• B0953300507: H3 PE INLAY SIZE 5- 7mm
• B0953300506: H3 PE INLAY SIZE 5- 6mm
• B0953300505: H3 PE INLAY SIZE 5- 5mm
• B0953300409: H3 PE INLAY SIZE 4- 9mm
• B0953300407: H3 PE INLAY SIZE 4- 7mm
• B0953300406: H3 PE INLAY SIZE 4 - 6 mm
• B0953300405: H3 PE INLAY SIZE 4- 5mm
• B0953300309: H3 PE INLAY SIZE 3- 9mm
• B0953300307: H3 PE INLAY SIZE 3 - 7mm
• B0953300306: H3 PE INLAY SIZE 3 - 6mm
• B0953300305: H3 PE INLAY SIZE 3 - 5mm
• B0953300209: H3 PE INLAY SIZE 2 - 9mm
• B0953300207: H3 PE INLAY SIZE 2 - 7mm
• B0953300206: H3 PE INLAY SIZE 2 - 6mm
• B0953300205: H3 PE INLAY SIZE 2 - 5mm
• B0953300109: H3 PE INLAY SIZE 1 - 9mm
• B0953300107: H3 PE INLAY SIZE 1 -7mm