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Duo Lumbar Interbody Fusion System

FDA UDI

Class II (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
Duo Lumbar Interbody Fusion System FDA UDI
Generic Name
Vertebral body bone graft pouch FDA UDI
Device Name
Duo LU Angled Trial, 10mm, 8° FDA UDI
Model / Reference
86-08-21-1 FDA UDI
Description
Duo LU Angled Trial, 10mm, 8° FDA UDI

Identifiers

Catalog Number
860-8100 FDA UDI
Primary DI / UDI-DI
M7408608100 FDA UDI
510(k) Number
K190055 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Vertebral body bone graft pouch 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Height — 10 Millimeter FDA UDI

Category: Polymeric spinal fusion cage, sterileVertebral body bone graft pouch

Duo Lumbar Interbody Fusion System by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertebral body bone graft pouch.

Cleared under the same submission

K190055 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI 4bead7b3-086b-4259-bb0a-5008f0244eeb 37 fields · synced May 30, 2026