← Back to catalogue

Duo

FDA UDI

Class II (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
Duo FDA UDI
Generic Name
Vertebral body bone graft pouch FDA UDI
Device Name
Duo Trial, 12mm NL FDA UDI
Model / Reference
86-30-09-12 FDA UDI
Description
Duo Trial, 12mm NL FDA UDI

Identifiers

Catalog Number
860-0103 FDA UDI
Primary DI / UDI-DI
M7408600103 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 — 12 Millimeter FDA UDI

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

Duo 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.

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 d923c391-2ba1-4f3a-92b5-34e5c4b3ec9b 36 fields · synced May 30, 2026