Metalogix Revolution

FDA UDI

Class I (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name: Metalogix Revolution FDA UDI
Generic Name: Bone nail end-cap FDA UDI
Device Name: 3mm Pin Cap FDA UDI
Model / Reference: 900109 FDA UDI
Description: 3mm Pin Cap FDA UDI

Identifiers

Catalog Number: 900109 FDA UDI
Primary DI / UDI-DI: 00840124521285 FDA UDI
FDA Product Code: JDT FDA UDI
GMDN Term: Bone nail end-cap FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.3000 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone nail end-cap

Metalogix Revolution by Fusion Orthopedics, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Fusion Orthopedics, Llc

Sources (1)

FDA UDI 76dc540d-2584-4cc9-b4c0-fc81d9231275 34 fields · synced May 30, 2026