Integra® TruArch® TRUARCHIMP
GUDID M268TRUARCHIMP1
The Integra TruArch subtalar implant is a one-piece titanium implant for treating hyperpronation of the foot. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. The implant is offered in 5 sizes ranging from 8mm to 12mm in diameter. The system includes instruments to facilitate the placement of the implants.
Ascension Orthopedics, Inc.
Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable, sterile Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable Subtalar implant, non-bioabsorbable| Primary Device ID | M268TRUARCHIMP1 |
| NIH Device Record Key | a42acb4c-2758-4574-b964-226d2bcca2b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® TruArch® |
| Version Model Number | TRUARCHIMP |
| Catalog Number | TRUARCHIMP |
| Company DUNS | 942377524 |
| Company Name | Ascension Orthopedics, Inc. |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
Customer Support Contacts
| 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 | |
| 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 | |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780074342 [Primary] |
| HIBCC | M268TRUARCHIMP1 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111265
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
[M268TRUARCHIMP1]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-07-16 |
| Device Publish Date | 2015-09-22 |
On-Brand Devices [Integra® TruArch®]
| 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 |
Trademark Results [Integra]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.