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Axis Spine Technologies ALIF

FDA UDI

Class II (US FDA UDI)

by Axis Spine Technologies Ltd

Identity

Trade Name
Axis Spine Technologies ALIF FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
ALIF Core Trial - 6x15 FDA UDI
Model / Reference
A6060615 FDA UDI
Description
ALIF Core Trial - 6x15 FDA UDI

Identifiers

Primary DI / UDI-DI
05060771802963 FDA UDI
510(k) Number
K200352 FDA UDI
FDA Product Code
OVD 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

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

Category: Spinal implant trial

Axis Spine Technologies ALIF by Axis Spine Technologies Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K200352 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Axis Spine Technologies Ltd

Sources (1)

  • FDA UDI 453b885d-aa9d-43bd-83d1-04d062d17211 35 fields · synced May 30, 2026