FLXfit 15

FDA UDI

Class II (US FDA UDI)

by Corelink Llc

Identity

Trade Name: FLXfit 15 FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: FLXfit 15 Expandable Interbody FDA UDI
Model / Reference: AT3208 FDA UDI
Description: FLXfit 15 Expandable Interbody FDA UDI

Identifiers

Primary DI / UDI-DI: M725AT32080 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Metallic spinal interbody fusion cage 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

Yes

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

MRI Safety

MR Unsafe FDA UDI

Category: Metallic spinal interbody fusion cage

FLXfit 15 by Corelink Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MectaLIF 3D — Medacta International · Class II
PILLAR TL — Orthofix US LLC · Class II
Solar™ Interbody Fusion System — Degen Medical · Class II
Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · 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

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Manufacturer

Manufacturer: Corelink Llc

Sources (1)

FDA UDI 475ab655-9828-47f9-b092-0387dde825c7 33 fields · synced Jun 8, 2026