Align

FDA UDI

Class II (US FDA UDI)

by Acuity Surgical Devices, Llc

Identity

Trade Name: Align FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: Align Ti Lateral Interbody 22x55x15 12° FDA UDI
Model / Reference: 16-22551512 FDA UDI
Description: Align Ti Lateral Interbody 22x55x15 12° FDA UDI

Identifiers

Primary DI / UDI-DI: 00810043486682 FDA UDI
510(k) Number: K221535 FDA UDI
FDA Product Code: OVD FDA UDI
GMDN Term: Metallic spinal interbody fusion cage 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 22 Millimeter FDA UDI
Width — 55 Millimeter FDA UDI
Height — 15 Millimeter FDA UDI
Angle — 12 degree FDA UDI

Category: Metallic spinal interbody fusion cage

Align Ti Lateral Interbody 22x55x15 12° is a metallic spinal interbody fusion cage designed for use in the treatment of degenerative disc disease. It features a hollow, porous design that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur, typically using bone graft to help with osseointegration.

Similar devices

Also classified as Metallic spinal interbody fusion cage.

KODIAK CERVICAL IMPLANT, 14x16mm, 10mmx6° — MET 1 TECHNOLOGIES, LLC · Class II
Peridot-PT Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
CoRoent — Nuvasive, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
MectaLIF 3D — Medacta International · Class II
PILLAR TL — Orthofix US LLC · Class II
Solar™ Interbody Fusion System — Degen Medical · Class II
Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Acuity Surgical Devices, Llc

Sources (1)

FDA UDI 7926a2dc-21e2-42d0-a6f0-0e404f04319a 36 fields · synced Jul 18, 2026