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ABTross ALIF Expandable Cage System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K221719

by Aegis Spine, Inc.

Identity

Trade Name
ABTross ALIF Expandable Cage System FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
ALIF 24x32x15~19mm, 20° FDA UDI
Model / Reference
2432-2015S FDA UDI
Description
ALIF 24x32x15~19mm, 20° FDA UDI

Identifiers

Catalog Number
2432-2015S FDA UDI
Primary DI / UDI-DI
00840273320081 FDA UDI
510(k) Number
K221719 FDA 510(k)FDA UDI
FDA Product Code
MAX FDA 510(k)FDA UDI
GMDN Term
Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

ABTross ALIF Expandable Cage System by Aegis Spine, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aegis Spine, Inc.

Sources (2)

  • FDA 510(k) K221719 24 fields · synced Jun 18, 2026
  • FDA UDI 3e060ca2-6875-4176-9534-a22dd785fcef 35 fields · synced May 27, 2026