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Dakota ALIF System

FDA UDI

Class II (US FDA UDI)

by Precision Spine, Inc.

Identity

Trade Name
Dakota ALIF System FDA UDI
Generic Name
Polymeric spinal interbody fusion cage FDA UDI
Device Name
36X 28 X 15mm X 20° PEEK-2C FDA UDI
Model / Reference
69-AL-2015-2C FDA UDI
Description
36X 28 X 15mm X 20° PEEK-2C FDA UDI

Identifiers

Catalog Number
69-AL-2015-2C FDA UDI
Primary DI / UDI-DI
00840019963404 FDA UDI
510(k) Number
K213118 FDA UDI
FDA Product Code
OVD FDA UDI
MAX FDA UDI
GMDN Term
Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dakota ALIF System by Precision Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K213118 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Precision Spine, Inc.

Sources (1)

  • FDA UDI e54327f3-f8f6-49ae-b00e-ab8e1bff4d9e 36 fields · synced Jun 6, 2026