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Endoskeleton TCS

FDA UDI

Class II (US FDA UDI)

by Titan Spine, Inc.

Identity

Trade Name
Endoskeleton TCS FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Interbody Fusion Device 3.5mm Implant Bone Screw 16mm FDA UDI
Model / Reference
5301-3516 FDA UDI
Description
Interbody Fusion Device 3.5mm Implant Bone Screw 16mm FDA UDI

Identifiers

Catalog Number
5301-3516 FDA UDI
Primary DI / UDI-DI
M682530135160 FDA UDI
510(k) Number
K142940 FDA UDI
FDA Product Code
ODP FDA UDI
OVE FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 3.5 Millimeter FDA UDI
Length — 16 Millimeter FDA UDI

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

Cleared under the same submission

K142940 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 d701c202-969f-4ebb-a930-746978b392a3 38 fields · synced Jun 8, 2026