Fuji Cervical Plate System

GUDID B41711240141

Cortical-Cancellous Variable Angle Self-Drilling Screw, 4.0mm Diameter x Length 14mm

Altus Spine, LLC

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device IDB41711240141
NIH Device Record Key967b82df-dde6-4107-b057-2fac5dab5592
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuji Cervical Plate System
Version Model Number112-4014
Company DUNS078331322
Company NameAltus Spine, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com
Phone+1(610)355-4156
EmailInfo@altus-spine.com

Device Dimensions

Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter
Length14 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100843210102788 [Secondary]
HIBCCB41711240141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

[B41711240141]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-22

On-Brand Devices [Fuji Cervical Plate System]

00843210133317Sizing Compass
00843210133300Self Retaining Driver
00843210133294Fuji Plate Bender
00843210133287Fixed Angle Centralizer
00843210133270Variable Angle Centralizer
00843210133256Double Barrell Drill Guide 10°
00843210133249Double Barrel Drill Guide 28°
00843210133232Plate Holder
00843210133225SSP: Quick Connect Handle
00843210133218SSP: Trocar Awl 2.5mm
00843210133201SSP: SCP Screwdriver
00843210133188SSP: Utility Driver
00843210121826Twist Drill, 4mm x 16mm
00843210121819Twist Drill, 4mm x 14mm
00843210121802Twist Drill, 4mm x 12mm
0084321012166632mm Level 2 Cervical Plate System-Fuji
0084321012165930mm Level 2 Cervical Plate System-Fuji
00843210118703Fixation Pin
B417139402214.0mm x 22mm Cort./Cancellous Screw, Fixed Angle Self-Drilling
B417139402014.0mm x 20mm Cort./Cancellous Screw, Fixed Angle Self-Drilling
B417139401814.0mm x 18mm Cort./Cancellous Screw, Fixed Angle Self-Drilling
B417139401614.0mm x 16mm Cort./Cancellous Screw, Fixed Angle Self-Drilling
B417139401514.0mm x 15mm Cort./Cancellous Screw, Fixed Angle Self-Drilling
B417139401414.0mm x 14mm Cort./Cancellous Screw, Fixed Angle Self-Drilling
B417139401314.0mm x 13mm Cort./Cancellous Screw, Fixed Angle Self-Drilling
B417139401214.0mm x 12mm Cort./Cancellous Screw, Fixed Angle Self-Drilling
B417138432214.35mm x 22mm Screw, Fixed Angle Self-Drilling, Fuji
B417138432014.35mm x 20mm Screw, Fixed Angle Self-Drilling, Fuji
B417138431814.35mm x 18mm Screw, Fixed Angle Self-Drilling, Fuji
B417138431614.35mm x 16mm Screw, Fixed Angle Self-Drilling, Fuji
B417138431514.35mm x 15mm Screw, Fixed Angle Self-Drilling, Fuji
B417138431414.35mm x 14mm Screw, Fixed Angle Self-Drilling, Fuji
B417138431314.35mm x 13mm Screw, Fixed Angle Self-Drilling, Fuji
B417138431214.35mm x 12mm Screw, Fixed Angle Self-Drilling, Fuji
B417138402214.0mm x 22mm Screw, Fixed Angle Self-Drilling, Fuji
B417138402014.0mm x 20mm Screw, Fixed Angle Self-Drilling, Fuji
B417138401814.0mm x 18mm Screw, Fixed Angle Self-Drilling, Fuji
B417138401614.0mm x 16mm Screw, Fixed Angle Self-Drilling, Fuji
B417138401514.0mm x 15mm Screw, Fixed Angle Self-Drilling, Fuji
B417138401414.0mm x 14mm Screw, Fixed Angle Self-Drilling, Fuji
B417138401314.0mm x 13mm Screw, Fixed Angle Self-Drilling, Fuji
B417138401214.0mm x 12mm Screw, Fixed Angle Self-Drilling, Fuji
B41713743181Rigid Self-Tapping Screw, 4.35mm Diameter x Length 18mm, Fuji
B41713743161Rigid Self-Tapping Screw, 4.35mm Diameter x Length 16mm, Fuji
B41713743141Rigid Self-Tapping Screw, 4.35mm Diameter x Length 14mm, Fuji
B41713743121Rigid Self-Tapping Screw, 4.35mm Diameter x Length 12mm, Fuji
B41713740221Anterior Cervical Fusion Plate, 1 Level, 22mm
B41713740201Cortical-Cancellous Fixed Angle Self-Tapping Screw, 4.0mm Diameter x Length 20mm
B41713740181Rigid Self-Tapping Screw, 4.0mm Diameter x Length 18mm, Fuji
B41713740161Rigid Self-Tapping Screw, 4.0mm Diameter x Length 16mm, Fuji
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