Kyocera Medical Technologies, Inc.

FDA UDI

Class II (US FDA UDI)

by Kyocera Medical Technologies, Inc.

Identity

Trade Name: Kyocera Medical Technologies, Inc. FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: 4.5mm X 30mm Constrained Screw FDA UDI
Model / Reference: Tesera FDA UDI
Description: 4.5mm X 30mm Constrained Screw FDA UDI

Identifiers

Catalog Number: 1029-453-030 FDA UDI
Primary DI / UDI-DI: 00841523117833 FDA UDI
510(k) Number: K131122 FDA UDI
K140106 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Metallic spinal interbody fusion cage

Kyocera Medical Technologies, Inc. by Kyocera Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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
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
ShurFit Lumbar Interbody — Precision Spine, Inc. · Class II

Cleared under the same submission

K131122 also covers:

K140106 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: Kyocera Medical Technologies, Inc.

Sources (1)

FDA UDI c1b51747-6f78-4224-a467-dc1e12f6e944 35 fields · synced May 30, 2026