Identity
- Trade Name
- Integra® External Fixation System FDA UDI
- Generic Name
- External orthopaedic fixation system, reusable FDA UDI
- Device Name
- The Integra External Fixation System half pin bone screws are manufactured from stainless steel and are secured to the bone segment. The half pins come with both self-tapping and self-drilling design features. They are intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation. FDA UDI
- Model / Reference
- 12220035 FDA UDI
- Description
- The Integra External Fixation System half pin bone screws are manufactured from stainless steel and are secured to the bone segment. The half pins come with both self-tapping and self-drilling design features. They are intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation. FDA UDI
Identifiers
- Catalog Number
- 12220035 FDA UDI
- Primary DI / UDI-DI
- 10381780125020 FDA UDI
- 510(k) Number
- K140463 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- External orthopaedic fixation system, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- 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
Category: External orthopaedic fixation system, reusable
Integra® External Fixation System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as External orthopaedic fixation system, reusable.
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- TransFx™ — Zimmer, Inc. · Class I
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Cleared under the same submission
K140463 also covers:
- Integra® External Fixation System — Ascension Orthopedics, Inc.
- Integra® External Fixation System — Ascension Orthopedics, Inc.
- Integra® External Fixation System — Ascension Orthopedics, Inc.
- Integra® External Fixation System — Ascension Orthopedics, Inc.
- Integra® External Fixation System — Ascension Orthopedics, Inc.
- Integra® External Fixation System — Ascension Orthopedics, Inc.
- Integra® External Fixation System — Ascension Orthopedics, Inc.
- Integra® External Fixation System — Ascension Orthopedics, Inc.
- Integra® External Fixation System — Ascension Orthopedics, Inc.
- Integra® External Fixation System — Ascension Orthopedics, Inc.
- Integra® External Fixation System — Ascension Orthopedics, Inc.
- Integra® External Fixation 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 4be1ca9d-4985-47e3-bc8c-821df4fc0292 38 fields · synced May 30, 2026