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ALEUTIAN® Interbody Systems

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
ALEUTIAN® Interbody Systems FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
Trial Size 12x14x7 mm, 7° FDA UDI
Model / Reference
SP-4214-14 FDA UDI
Description
Trial Size 12x14x7 mm, 7° FDA UDI

Identifiers

Catalog Number
SP-4214-14 FDA UDI
Primary DI / UDI-DI
10888857521384 FDA UDI
FDA Product Code
ODP FDA UDI
MQP FDA UDI
MAX FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
888.3060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Dimensions & Sizes

Size
Height — 7 Millimeter FDA UDI
Width — 12 Millimeter FDA UDI
Angle — 7 degree FDA UDI
Depth — 14 Millimeter FDA UDI

Category: General internal orthopaedic fixation system implantation kit

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

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI caa26b85-d2e4-4890-bc6f-3d0064e2c1d7 36 fields · synced May 30, 2026