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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
Surgical instrument/implant depth limiter, reusable FDA UDI
Device Name
ALIF Divergent Screw Guide FDA UDI
Model / Reference
A6160100 FDA UDI
Description
ALIF Divergent Screw Guide FDA UDI

Identifiers

Primary DI / UDI-DI
05060771803724 FDA UDI
510(k) Number
K200352 FDA UDI
FDA Product Code
OVD FDA UDI
GMDN Term
Surgical instrument/implant depth limiter, reusable 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: Surgical instrument/implant depth limiter, reusable

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 Surgical instrument/implant depth limiter, reusable.

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 f4e02341-3b4d-417a-b5f3-30a2716e9cfa 35 fields · synced Jun 6, 2026