TiNano

FDA UDI

Class II (US FDA UDI)

by Aurora Spine, Inc.

Identity

Trade Name: TiNano FDA UDI
Generic Name: Polymeric spinal fusion cage, sterile FDA UDI
Device Name: ECHO XL Lumbar Interbody Fusion System, 26mm x 10mm x 4 degrees x 14mm FDA UDI
Model / Reference: ECHO XL FDA UDI
Description: ECHO XL Lumbar Interbody Fusion System, 26mm x 10mm x 4 degrees x 14mm FDA UDI

Identifiers

Catalog Number: 108-82610-0414 FDA UDI
Primary DI / UDI-DI: B5211088261004140 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 — 4 degree FDA UDI
Width — 10 Millimeter FDA UDI
Length — 26 Millimeter FDA UDI

Category: Polymeric spinal fusion cage, sterile

TiNano 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

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

Manufacturer

Manufacturer: Aurora Spine, Inc.

Sources (1)

FDA UDI 30a5b42d-8940-4f8e-86e4-7d8d9827abae 37 fields · synced May 30, 2026