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 open wedge plate is used for fixation for a variety of proximal metatarsal osteotomies. The stem is deepened and tapered for distraction of osteotomy during insertion and solid contact against cortical bone. It contains distal screw holes that are narrowed for an anatomic fit along the distal metatarsal and stems moved proximally on plate to minimize potential interference with proximal joint FDA UDI
- Model / Reference
- 2832106 FDA UDI
- Description
- The Integra Total Foot System open wedge plate is used for fixation for a variety of proximal metatarsal osteotomies. The stem is deepened and tapered for distraction of osteotomy during insertion and solid contact against cortical bone. It contains distal screw holes that are narrowed for an anatomic fit along the distal metatarsal and stems moved proximally on plate to minimize potential interference with proximal joint FDA UDI
Identifiers
- Catalog Number
- 2832106 FDA UDI
- Primary DI / UDI-DI
- 10381780119227 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
- Not 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
Integra® Total Foot System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 fe8c513a-ca96-4b88-86ce-8949b1abb807 38 fields · synced Jun 6, 2026