Endoskeleton® Tl

FDA UDI

Class II (US FDA UDI)

by Titan Spine, Inc.

Identity

Trade Name: ENDOSKELETON® TL FDA UDI
Generic Name: Surgical gouge FDA UDI
Device Name: Box Chisel, Straight, 18mm x 4mm FDA UDI
Model / Reference: 7200-1134 FDA UDI
Description: Box Chisel, Straight, 18mm x 4mm FDA UDI

Identifiers

Catalog Number: 7200-1134 FDA UDI
Primary DI / UDI-DI: 00191375043089 FDA UDI
510(k) Number: K140055 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Surgical gouge 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: Height — 4 Millimeter FDA UDI
Width — 18 Millimeter FDA UDI
Length — 12.5 Inch 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 cf746d52-cb1c-4be0-91b6-9b1c8370340c 38 fields · synced May 31, 2026