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: 14-534237 FDA UDI

Identifiers

Catalog Number: 14-534237 FDA UDI
Primary DI / UDI-DI: 00888480612889 FDA UDI
FDA Product Code: MAX FDA UDI
MQP FDA UDI
GMDN Term: Polymeric spinal fusion cage, sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
888.3060 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

Similar devices

Also classified as Polymeric spinal fusion cage, sterile.

TALOS® IBF — MEDITECH SPINE, LLC · Class II
ROCCIA — Silony Medical GmbH · Class II
TiNano — AURORA SPINE, INC. · Class II
EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II
Aurora Spine — AURORA SPINE, INC. · Class II
TALOS®-C — MEDITECH SPINE, LLC · Class II
Avenue T — Ldr Spine USA · Class II
EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Biomet Spine Llc

Sources (1)

FDA UDI ead8f7c6-13d5-422b-8890-cefc65fcd849 35 fields · synced Jun 8, 2026