IDENTITI NanoTec

FDA UDI

Class II (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name: IDENTITI NanoTec FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: IDENTITi NanoTec CERVICAL POROUS Ti SPACER, 10 x 22 x 19 mm, 7° FDA UDI
Model / Reference: 126-PRO-10221907-S FDA UDI
Description: IDENTITi NanoTec CERVICAL POROUS Ti SPACER, 10 x 22 x 19 mm, 7° FDA UDI

Identifiers

Primary DI / UDI-DI: 00190376411866 FDA UDI
510(k) Number: K211805 FDA UDI
FDA Product Code: ODP 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

Yes

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

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Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 10 Millimeter FDA UDI
Width — 22 Millimeter FDA UDI
Depth — 19 Millimeter FDA UDI
Angle — 7 degree FDA UDI

Category: Metallic spinal interbody fusion cage

The IDENTITI NanoTec CERVICAL POROUS Ti SPACER is a cutting-edge, minimally invasive cervical porous titanium spacer designed for the treatment of degenerative disc disease. This device provides a stable and safe space for bone fusion to occur, utilizing a unique combination of mechanical stability and sufficient space for therapeutic spinal bone fusion.

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: Alphatec Spine, Inc.

Sources (1)

FDA UDI 3beb760e-45a2-41db-8b88-cb1e30b5a934 36 fields · synced Jul 20, 2026