← Back to catalogue

Duo Lumbar Interbody Fusion Device

FDA UDI

Class II (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
Duo Lumbar Interbody Fusion Device FDA UDI
Generic Name
Vertebral body bone graft pouch FDA UDI
Device Name
Duo, Lordotic, 55 x 10mm FDA UDI
Model / Reference
10-10-05-29 FDA UDI
Description
Duo, Lordotic, 55 x 10mm FDA UDI

Identifiers

Catalog Number
291-5510 FDA UDI
Primary DI / UDI-DI
M7402915510 FDA UDI
510(k) Number
K160074 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 55 Millimeter FDA UDI

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

Duo Lumbar Interbody Fusion Device 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

K160074 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI 275bafe9-2e89-4f27-9277-860ead9250d1 37 fields · synced Jun 6, 2026