Aurora Spine

FDA UDI

Class II (US FDA UDI)

by Aurora Spine, Inc.

Identity

Trade Name: Aurora Spine FDA UDI
Generic Name: Polymeric spinal fusion cage, sterile FDA UDI
Device Name: AFFINITY Lumbar Interbody Fusion System, 26mm x 34mm x 6 degrees x 14mm, UNCOATED FDA UDI
Model / Reference: AFFINITY FDA UDI
Description: AFFINITY Lumbar Interbody Fusion System, 26mm x 34mm x 6 degrees x 14mm, UNCOATED FDA UDI

Identifiers

Catalog Number: 106-02634-0614-UC FDA UDI
Primary DI / UDI-DI: B521106026340614UC0 FDA UDI
510(k) Number: K133967 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Polymeric spinal fusion cage, 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

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

Dimensions & Sizes

Size: Height — 14 Millimeter FDA UDI
Angle — 6 degree FDA UDI
Width — 34 Millimeter FDA UDI
Length — 26 Millimeter FDA UDI

Category: Polymeric spinal fusion cage, sterile

Aurora Spine by Aurora Spine, Inc. — 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
EVOS Lumbar Interbody System — CUTTING EDGE SPINE · 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
VertebraLINK MI — LINKSPINE, INC. · Class I
TALOS® IBF — MEDITECH SPINE, LLC · Class II

Cleared under the same submission

K133967 also covers:

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: Aurora Spine, Inc.

Sources (1)

FDA UDI 5470755a-32fa-473b-942f-8248e36a666c 37 fields · synced Jun 7, 2026