Zyston Straight Spacer Sys

FDA UDI

Class II (US FDA UDI)

by Biomet Spine Llc

Identity

Trade Name: ZYSTON STRAIGHT SPACER SYS FDA UDI
Generic Name: Polymeric spinal fusion cage, sterile FDA UDI
Model / Reference: 14-534210 FDA UDI

Identifiers

Catalog Number: 14-534210 FDA UDI
Primary DI / UDI-DI: 00888480612735 FDA UDI
FDA Product Code: MQP FDA UDI
MAX FDA UDI
GMDN Term: Polymeric spinal fusion cage, sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Polymeric spinal fusion cage, sterile

Zyston Straight Spacer Sys 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 ee5e6b1a-f3c5-4057-9be1-af7358709fb0 35 fields · synced May 29, 2026