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Integra® Total Wrist Fusion System

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
Integra® Total Wrist Fusion System FDA UDI
Generic Name
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name
The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight holes and a straight plate with nine holes. These plates are fixed to the bone with 2.7mm diameter and 3.5mm diameter screws. Instrumentation is provided to assist in the implantation. Screws with a diameter of 2.7mm vary in size length from 10mm to 24mm. Screws with a diameter of 3.5mm vary in size length from 12mm to 28mm. This system is generally indicated for use in patients with arthritis of the joints of the wrist, rheumatoid wrist deformities, carpal instability, wrist pain, brachial plexus nerve palsies, and loss of function due to osteoarthritis. FDA UDI
Model / Reference
WRISTFUSESET FDA UDI
Description
The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight holes and a straight plate with nine holes. These plates are fixed to the bone with 2.7mm diameter and 3.5mm diameter screws. Instrumentation is provided to assist in the implantation. Screws with a diameter of 2.7mm vary in size length from 10mm to 24mm. Screws with a diameter of 3.5mm vary in size length from 12mm to 28mm. This system is generally indicated for use in patients with arthritis of the joints of the wrist, rheumatoid wrist deformities, carpal instability, wrist pain, brachial plexus nerve palsies, and loss of function due to osteoarthritis. FDA UDI

Identifiers

Catalog Number
WRISTFUSESET FDA UDI
Primary DI / UDI-DI
10381780064350 FDA UDI
FDA Product Code
LXT FDA UDI
HRS FDA UDI
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable 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® Total Wrist Fusion System by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences Corp.

Sources (1)

  • FDA UDI 0ed23ab1-376b-4244-b23b-4e8602d40956 37 fields · synced Jun 6, 2026