Flux-C Cervical Interbody

FDA UDI

Class II (US FDA UDI)

by Ulrich Medical Usa, Inc.

Identity

Trade Name: Flux-C Cervical Interbody FDA UDI
Generic Name: Orthopaedic fixation implant alignment tool FDA UDI
Device Name: Trial, 16x14mm, 7mm height, 12-degree stopless FDA UDI
Model / Reference: UU082-72-1614-07 FDA UDI
Description: Trial, 16x14mm, 7mm height, 12-degree stopless FDA UDI

Identifiers

Primary DI / UDI-DI: 00810076336510 FDA UDI
FDA Product Code: ODP FDA UDI
GMDN Term: Orthopaedic fixation implant alignment tool FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic fixation implant alignment tool

Flux-C Cervical Interbody by Ulrich Medical Usa, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic fixation implant alignment tool.

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U-Motion II — UNITED ORTHOPEDIC CORP. · Class I
Easyspine — Ldr Spine USA · Class I
Nautilus Spinal System — Life Spine, Inc. · Class II
EVEREST Spinal System — K2M, 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 II	Pending data

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Manufacturer

Manufacturer: Ulrich Medical Usa, Inc.

Sources (1)

FDA UDI 5a58bd44-f72f-4a11-95c2-fa39c2c6bd29 34 fields · synced May 30, 2026