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Metalogix Revolution

FDA UDI

Class II (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name
Metalogix Revolution FDA UDI
Generic Name
Orthopaedic bone bolt FDA UDI
Device Name
Standard Bolt FDA UDI
Model / Reference
100065 FDA UDI
Description
Standard Bolt FDA UDI

Identifiers

Catalog Number
100065 FDA UDI
Primary DI / UDI-DI
00850069061012 FDA UDI
FDA Product Code
HTN FDA UDI
GMDN Term
Orthopaedic bone bolt 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone bolt

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

Similar devices

Also classified as Orthopaedic bone bolt.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fusion Orthopedics, Llc

Sources (1)

  • FDA UDI 3bde36bf-2104-4d04-a56f-8a960f089062 34 fields · synced May 31, 2026