Endoskeleton® Tl

FDA UDI

Class II (US FDA UDI)

by Titan Spine, Inc.

Identity

Trade Name: ENDOSKELETON® TL FDA UDI
Generic Name: Spinal implant trial FDA UDI
Device Name: Trial, 12 Deg Lordotic, Straight, 22mm x 9mm FDA UDI
Model / Reference: 7212-1509 FDA UDI
Description: Trial, 12 Deg Lordotic, Straight, 22mm x 9mm FDA UDI

Identifiers

Catalog Number: 7212-1509 FDA UDI
Primary DI / UDI-DI: 00191375041566 FDA UDI
510(k) Number: K140055 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Spinal implant trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 60 Millimeter FDA UDI
Angle — 12 degree FDA UDI
Width — 22 Millimeter FDA UDI
Height — 9 Millimeter FDA UDI

Endoskeleton® Tl by Titan Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K140055 also covers:

ENDOSKELETON® TL — MEDTRONIC SOFAMOR DANEK, INC.

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: Titan Spine, Inc.

Sources (1)

FDA UDI ba4f554e-d0bf-4404-97ea-c7d81a4b88f2 38 fields · synced May 31, 2026