Identity
- Trade Name
- Integra® Total Foot System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- The Integra Total Foot System Tarsalis Plate is a 4-hole T-shaped utility plate used for fixation of osteotomies and fractures throughout the foot. FDA UDI
- Model / Reference
- 2807104 FDA UDI
- Description
- The Integra Total Foot System Tarsalis Plate is a 4-hole T-shaped utility plate used for fixation of osteotomies and fractures throughout the foot. FDA UDI
Identifiers
- Catalog Number
- 2807104 FDA UDI
- Primary DI / UDI-DI
- 10381780119777 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Integra® Total Foot System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable, non-sterile.
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Cleared under the same submission
K100502 also covers:
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
K123000 also covers:
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
- Integra® Total Foot System — Ascension Orthopedics, Inc.
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 3936f284-3d31-4a14-8978-f3fcb628166d 38 fields · synced Jun 8, 2026