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Endoskeleton TL

FDA UDI

Class II (US FDA UDI)

by Titan Spine, Inc.

Identity

Trade Name
Endoskeleton TL FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
Interbody Fusion Device nanoLOCK Surface Technology Parallel 40 (M/L) 22 (A/P) 16 mm FDA UDI
Model / Reference
7100-1116-N FDA UDI
Description
Interbody Fusion Device nanoLOCK Surface Technology Parallel 40 (M/L) 22 (A/P) 16 mm FDA UDI

Identifiers

Catalog Number
7100-1116-N FDA UDI
Primary DI / UDI-DI
M68271001116N0 FDA UDI
510(k) Number
K140055 FDA UDI
K141953 FDA UDI
FDA Product Code
MAX 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 22 Millimeter FDA UDI
Length — 40 Millimeter FDA UDI
Height — 16 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:

K141953 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Titan Spine, Inc.

Sources (1)

  • FDA UDI 26d37c3c-d903-419b-a5ae-1cdeaf0e1c20 38 fields · synced May 31, 2026