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Integra® External Fixation System

FDA UDI

Class II (US FDA UDI)

by Ascension Orthopedics, Inc.

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 set consists of wires, half-pins, nuts, and bolts. Instruments are also included to aid in assembly. The external fixation device is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. FDA UDI
Model / Reference
XFIX1BOLTIMP FDA UDI
Description
The Integra External Fixation System set consists of wires, half-pins, nuts, and bolts. Instruments are also included to aid in assembly. The external fixation device is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. FDA UDI

Identifiers

Catalog Number
XFIX1BOLTIMP FDA UDI
Primary DI / UDI-DI
10381780125709 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Integra® External Fixation System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K140463 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 45dd8a2d-cfe8-449e-b152-1ed551ce8fbb 37 fields · synced Jun 1, 2026