Endoskeleton® Tcs

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: ENDOSKELETON® TCS FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Device Name: Interbody Fusion Device 6 Degree Large 9mm FDA UDI
Model / Reference: 5386-1609 FDA UDI
Description: Interbody Fusion Device 6 Degree Large 9mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00191375011057 FDA UDI
510(k) Number: K142940 FDA UDI
K151596 FDA UDI
K173535 FDA UDI
K183557 FDA UDI
K191565 FDA UDI
K192018 FDA UDI
FDA Product Code: ODP FDA UDI
OVE 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: Angle — 6 degree FDA UDI
Depth — 16 Millimeter FDA UDI
Width — 18 Millimeter FDA UDI
Height — 9 Millimeter FDA UDI

Category: Metallic spinal interbody fusion cage

Endoskeleton® Tcs by Medtronic Sofamor Danek, 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
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

K173535 also covers:

K183557 also covers:

K192018 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: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI f88f84b0-34cb-452d-8fee-6075c233c291 36 fields · synced May 30, 2026