Sidekick

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name: SIDEKICK FDA UDI
Generic Name: External orthopaedic fixation system, reusable FDA UDI
Model / Reference: RR1458CE FDA UDI

Identifiers

Catalog Number: RR1458CE FDA UDI
Primary DI / UDI-DI: 00840420128065 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

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Single Use

Yes

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Implantable

Yes

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Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

Yes

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 140 Millimeter FDA UDI

Category: External orthopaedic fixation system, reusable

The SIDEKICK medical device is an external orthopaedic fixation system designed to stabilize fractured bones, other than those in the vertebral column, promoting treatment and healing. It consists of a reusable assembly of devices that includes an external fixator, clamps, rods, rings, cams, bushings, collars, bolts, nuts, and instrumentation for long bone stabilization.

Similar devices

Also classified as External orthopaedic fixation system, reusable.

HOFFMANN — Stryker Corp. · Class II
ADVANCED LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
Integra® External Fixation System — Ascension Orthopedics, Inc. · Class II
PAEDIATRIC LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc. · Class II
TransFx™ — Zimmer, Inc. · Class I
HOFFMANN — Stryker Corp. · Class II
TENXOR — Stryker Corp. · Class II

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: Wright Medical Technology, Inc.

Sources (1)

FDA UDI 0b359cfb-4502-4e79-8571-9a377b0dfd07 35 fields · synced Jul 9, 2026