Identity
- Trade Name
- Integra® TruArch® FDA UDI
- Generic Name
- Subtalar implant, non-bioabsorbable FDA UDI
- Device Name
- The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperpronation of the foot. FDA UDI
- Model / Reference
- TA1100 FDA UDI
- Description
- The Integra® TruArch® subtalar implant is a one-piece titanium implant for treating hyperpronation of the foot. FDA UDI
Identifiers
- Catalog Number
- TA1100 FDA UDI
- Primary DI / UDI-DI
- 10381780119968 FDA UDI
- 510(k) Number
- K111265 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Subtalar implant, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Integra® TruArch® by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 9eaab988-4fb3-473f-9d3c-a8f99bd53e8f 38 fields · synced Jun 6, 2026