restor3d Cervical Cage

FDA UDI

Class II (US FDA UDI)

by Restor3D

Identity

Trade Name: restor3d Cervical Cage FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx12Hx0 FDA UDI
Model / Reference: 1110-16131200 FDA UDI
Description: Titanium (Ti-6Al-4V) Cervical Cage, 16Wx13Dx12Hx0 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840097500669 FDA UDI
510(k) Number: K191812 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Metallic spinal interbody fusion cage

This Restor3d Cervical Cage is a titanium, intervertebral fusion device designed to stabilize and fuse two contiguous vertebral bodies after partial or total removal during surgery. Made of metal, it provides sufficient space for bone fusion while facilitating 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

K191812 also covers:

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: Restor3D

Sources (1)

FDA UDI 48b94674-cf03-4f74-9caf-0cfb4c4df584 34 fields · synced Jul 9, 2026