ALEUTIAN Interbody Systems

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name: ALEUTIAN Interbody Systems FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: Cervical Disc Trial Size 13x16x6 mm, 7° FDA UDI
Model / Reference: PRO-1255-10 FDA UDI
Description: Cervical Disc Trial Size 13x16x6 mm, 7° FDA UDI

Identifiers

Catalog Number: PRO-1255-10 FDA UDI
Primary DI / UDI-DI: 10888857555983 FDA UDI
FDA Product Code: ODP FDA UDI
MAX FDA UDI
GMDN Term: Spinal implant trial 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

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Height — 6 Millimeter FDA UDI
Angle — 7 degree FDA UDI
Width — 16 Millimeter FDA UDI
Length — 13 Millimeter FDA UDI

Category: Spinal implant trial

ALEUTIAN Interbody Systems by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: K2m, Inc.

Sources (1)

FDA UDI 8b497c21-0b61-4ad7-b289-3ddc6dbae2a6 36 fields · synced May 31, 2026