Hintermann Series H2 322825
GUDID B0953228251
H2 TIBIAL TRAY SIZE 5 - LEFT (9.5MM)
DT MEDTECH, LLC
Coated ankle tibia prosthesis| Primary Device ID | B0953228251 |
| NIH Device Record Key | be8ba296-c942-4caa-8de4-77f3c74c10c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hintermann Series H2 |
| Version Model Number | 1 |
| Catalog Number | 322825 |
| 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 | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 999-999-9999 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 999-999-9999 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 999-999-9999 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 999-999-9999 |
| quality@dtmedtech.com | |
| Phone | 410-427-0003 |
| quality@dtmedtech.com | |
| Phone | 999-999-9999 |
| quality@dtmedtech.com | |
| Phone | 999-999-9999 |
| quality@dtmedtech.com | |
| Phone | 999-999-9999 |
| quality@dtmedtech.com | |
| Phone | 999-999-9999 |
| quality@dtmedtech.com | |
| Phone | 999-999-9999 |
| quality@dtmedtech.com | |
| Phone | 999-999-9999 |
| quality@dtmedtech.com | |
| Phone | 999-999-9999 |
| quality@dtmedtech.com | |
| Phone | 999-999-9999 |
| quality@dtmedtech.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B0953228251 [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 | 1 |
| Public Version Date | 2020-01-21 |
| Device Publish Date | 2020-01-13 |
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 |
Trademark Results [Hintermann Series H2]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HINTERMANN SERIES H2 86848301 5453980 Live/Registered |
DT MEDTECH, LLC 2015-12-14 |
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