Am

FDA UDI

Class I (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name: AM FDA UDI
Generic Name: Orthopaedic implantation sleeve, reusable FDA UDI
Device Name: Plantar Stop Device FDA UDI
Model / Reference: AMCE3305 FDA UDI
Description: Plantar Stop Device FDA UDI

Identifiers

Catalog Number: AMCE3305 FDA UDI
Primary DI / UDI-DI: 00889797043533 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic implantation sleeve, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

FDA UDI

HCT/P

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Premarket Exempt

Yes

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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

Category: Orthopaedic implantation sleeve, reusable

A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue.

Similar devices

Also classified as Orthopaedic implantation sleeve, reusable.

Arthrex® — Arthrex, Inc. · Class I
gSource — GSOURCE, LLC. · Class I
FITBONE TAA SYSTEM — Orthofix, Inc. · Class II
RIGID SUPRA ENTRY SLEEVE 13MM — Zimmer, Inc. · Class I
Jet-X — Smith & Nephew, Inc. · Class II
Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class I
Salvo® Spine System — Spine Wave, Inc. · Class I
DRILL SLEEVE — Biomet Orthopedics, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Wright Medical Technology, Inc.

Sources (1)

FDA UDI 87a6c66d-7a51-4b12-98b0-e717075ef1a1 35 fields · synced Jul 10, 2026