| Primary Device ID | M269TA30101 |
| NIH Device Record Key | 6f21119c-7130-44bf-b75c-c7b3b6335892 |
| Commercial Distribution Discontinuation | 2023-03-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Integra® TruArch® |
| Version Model Number | TA3010 |
| Company DUNS | 942377524 |
| Company Name | Ascension Orthopedics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780237426 [Primary] |
| HIBCC | M269TA30101 [Secondary] |
| HWT | TEMPLATE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
[M269TA30101]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2023-05-03 |
| Device Publish Date | 2016-08-15 |
| M268TRUARCHIMP1 | The Integra TruArch subtalar implant is a one-piece titanium implant for treating hyperpronation |
| 10381780119975 | The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperprona |
| 10381780119968 | The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperprona |
| 10381780119951 | The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperprona |
| 10381780119944 | The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperprona |
| 10381780119937 | The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperprona |
| M269TA30121 | The TruArch trial sizer is used to visualize the implant trial size and anticiapte the amount of |
| M269TA30111 | The TruArch trial sizer is used to visualize the implant trial size and anticiapte the amount of |
| M269TA30091 | The TruArch trial sizer is used to visualize the implant trial size and anticiapte the amount of |
| M269TA30081 | The TruArch trial sizer is used to visualize the implant trial size and anticiapte the amount of |
| M269TA30101 | The TruArch trial sizer is used to visualize the implant trial size and anticiapte the amount of |