Ortholoc 3di

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name: ORTHOLOC 3DI FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: Fusion Plate FDA UDI
Model / Reference: 58A10004 FDA UDI
Description: Fusion Plate FDA UDI

Identifiers

Catalog Number: 58A10004 FDA UDI
Primary DI / UDI-DI: 00889797101141 FDA UDI
FDA Product Code: 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

Ortholoc 3di by Wright Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic fixation plate, non-bioabsorbable.

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AXSOS — Stryker Corp. · Class II
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osteo-WEDGE2 12 Degree Angulated Bone Plate Implant, Large — Gramedica · 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 c4c37692-7407-43b0-abb2-1366e08d616c 36 fields · synced Jun 8, 2026