Invictus® Spinal Cement System

FDA UDI

Class II (US FDA UDI)

by Teknimed

Identity

Trade Name: Invictus® Spinal Cement System FDA UDI
Generic Name: Orthopaedic cement preparation/delivery kit FDA UDI
Model / Reference: 17095-S FDA UDI

Identifiers

Primary DI / UDI-DI: 03701505800559 FDA UDI
FDA Product Code: NDN FDA UDI
OAR FDA UDI
JDZ FDA UDI
GMDN Term: Orthopaedic cement preparation/delivery kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3027 FDA UDI
888.4200 FDA UDI
888.4210 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic cement preparation/delivery kit

Invictus® Spinal Cement System by Teknimed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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LITe BIO Delivery System — Stryker Corp. · Class II
VORTEX — Smith & Nephew, Inc. · Class I
StabiliT® — Merit Medical Systems, Inc. · Class II
CEMEX SYSTEM FAST 70G — Tecres · Class II

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: Teknimed

Sources (1)

FDA UDI b6df859e-938c-426b-9910-902bd9717564 32 fields · synced Jun 8, 2026