Ibex Spinal System

FDA UDI

Class II (US FDA UDI)

by Biomet Spine Llc

Identity

Trade Name: IBEX SPINAL SYSTEM FDA UDI
Generic Name: Metallic spinal fusion cage, non-sterile FDA UDI
Model / Reference: 5501015-00 FDA UDI

Identifiers

Catalog Number: 5501015-00 FDA UDI
Primary DI / UDI-DI: 00888480473886 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Metallic spinal fusion cage, non-sterile 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

Yes

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: Metallic spinal fusion cage, non-sterile

Ibex Spinal System by Biomet Spine Llc — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Biomet Spine Llc

Sources (1)

FDA UDI 7d63325b-61c9-4576-979e-5337a7f07e0c 35 fields · synced May 30, 2026