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ENDOSKELETON® TAS Hyperlordotic Sterile Barrier System

FDA UDI

Class II (US FDA UDI)

by Titan Spine, Inc.

Identity

Trade Name
ENDOSKELETON® TAS Hyperlordotic Sterile Barrier System FDA UDI
Generic Name
Metallic spinal interbody fusion cage FDA UDI
Device Name
Interbody Fusion Device 16 Degree Large 12mm FDA UDI
Model / Reference
2316-0212-S FDA UDI
Description
Interbody Fusion Device 16 Degree Large 12mm FDA UDI

Identifiers

Catalog Number
2316-0212-S FDA UDI
Primary DI / UDI-DI
00191375026655 FDA UDI
510(k) Number
K142589 FDA UDI
FDA Product Code
OVD 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
Depth — 24 Millimeter FDA UDI
Angle — 16 degree FDA UDI
Width — 36 Millimeter FDA UDI
Height — 12 Millimeter FDA UDI

ENDOSKELETON® TAS Hyperlordotic Sterile Barrier System by Titan Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 73abb311-277a-4ca6-9337-8048e24202b9 38 fields · synced May 31, 2026