Czar Fixed Self Drilling Screw 4.0

FDA UDI

Class II (US FDA UDI)

by Met 1 Technologies, Llc

Identity

Trade Name: CZAR FIXED SELF DRILLING SCREW 4.0 FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: THE MET ONE CZAR ANTERIOR CERVICAL PLATE SYSTEM IS INTENDED FOR ANTERIOR INTERBODY SCREW FIXATION OF THE CERVICAL SPINE. THE SYSTEM INCLUDES SCREWS, PLATES, AND A SET OF INSTRUMENTS TO INSERT THE IMPLANTS. PLATES ARE AVAILABLE IN A VARIETY OF LENGTHS TO ACCOMODATE FUSION PROCEDURES FROM ONE TO FOUR LEVELS OF THE CERVICAL SPINE. FIXATION IS ACHIEVED BY INSERTING THE SCREWS THROUGH THE OPENINGS IN THE PLATE INTO VERTEBRAL BODIES OF THE CERVICAL SPINE. THE PLATES ARE MANUFACTURED FROM TITANIUM 6 A1-4V ELI PER ASTM F136 AND INVIBIO PEEK-OPTIMA LT1 PER ASTM F2026. FDA UDI
Model / Reference: 64000112 FDA UDI
Description: THE MET ONE CZAR ANTERIOR CERVICAL PLATE SYSTEM IS INTENDED FOR ANTERIOR INTERBODY SCREW FIXATION OF THE CERVICAL SPINE. THE SYSTEM INCLUDES SCREWS, PLATES, AND A SET OF INSTRUMENTS TO INSERT THE IMPLANTS. PLATES ARE AVAILABLE IN A VARIETY OF LENGTHS TO ACCOMODATE FUSION PROCEDURES FROM ONE TO FOUR LEVELS OF THE CERVICAL SPINE. FIXATION IS ACHIEVED BY INSERTING THE SCREWS THROUGH THE OPENINGS IN THE PLATE INTO VERTEBRAL BODIES OF THE CERVICAL SPINE. THE PLATES ARE MANUFACTURED FROM TITANIUM 6 A1-4V ELI PER ASTM F136 AND INVIBIO PEEK-OPTIMA LT1 PER ASTM F2026. FDA UDI

Identifiers

Catalog Number: 64000112 FDA UDI
Primary DI / UDI-DI: 00819824024617 FDA UDI
510(k) Number: K180772 FDA UDI
FDA Product Code: KWQ FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 12 Millimeter FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

Czar Fixed Self Drilling Screw 4.0 by Met 1 Technologies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal fixation plate, non-bioabsorbable.

Zavation — ZAVATION · Class II
Cervalign — Xtant Medical Holdings, Inc. · Class II
CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc. · Class II
TSLP — Synthes · Class II
AESCULAP — AESCULAP, INC. · Class II
PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
ACP — Nuvasive, Inc. · Class II
uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II

Cleared under the same submission

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Met 1 Technologies, Llc

Sources (1)

FDA UDI 3a4e604f-5198-4606-9136-eb5801d0cda3 37 fields · synced May 30, 2026