FORTICO Anterior Cervical Fixation System

GUDID B030FCP4050

2-2, 10mm plate, standard, 5mm spacer

CAMBER SPINE TECHNOLOGIES, 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 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 IDB030FCP4050
NIH Device Record Keyff6cc163-6d86-4152-94c1-8f0c6ac8647d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFORTICO Anterior Cervical Fixation System
Version Model NumberFCP-405
Company DUNS054205979
Company NameCAMBER SPINE TECHNOLOGIES, 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

Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com
Phone18666430739
Emailcustomerservice@cambermedtech.com

Device Dimensions

Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter
Length10 Millimeter
Width16 Millimeter
Depth2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030FCP4050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


[B030FCP4050]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-04
Device Publish Date2020-08-27

On-Brand Devices [FORTICO Anterior Cervical Fixation System]

B030FCP21201-1, 17mm plate, standard, 12mm spacer
B030FCP21101-1, 16mm plate, standard, 11mm spacer
B030FCP21001-1, 15mm plate, standard, 10mm spacer
B030FCP20901-1, 14mm plate, standard, 9mm spacer
B030FCP20801-1, 13mm plate, standard, 8mm spacer
B030FCP20701-1, 12mm plate, standard, 7mm spacer
B030FCP20601-1, 11mm plate, standard, 6mm spacer
B030FCP20501-1, 10mm plate, standard, 5mm spacer
B030FCP232101-1, 21mm plate, standard
B030FCP232001-1, 20mm plate, standard
B030FCP231901-1, 19mm plate, standard
B030FCP31202-1, 17mm plate, standard, 12mm spacer
B030FCP31102-1, 16mm plate, standard, 11mm spacer
B030FCP31002-1, 15mm plate, standard, 10mm spacer
B030FCP30902-1, 14mm plate, standard, 9mm spacer
B030FCP30802-1, 13mm plate, standard, 8mm spacer
B030FCP30702-1, 12mm plate, standard, 7mm spacer
B030FCP30602-1, 11mm plate, standard, 6mm spacer
B030FCP30502-1, 10mm plate, standard, 5mm spacer
B030FCP241902-1, 19mm plate, standard
B030FCP234601-1, 46mm plate, standard
B030FCP234501-1, 45mm plate, standard
B030FCP234401-1, 44mm plate, standard
B030FCP234301-1, 43mm plate, standard
B030FCP234201-1, 42mm plate, standard
B030FCP234101-1, 41mm plate, standard
B030FCP234001-1, 40mm plate, standard
B030FCP233901-1, 39mm plate, standard
B030FCP233801-1, 38mm plate, standard
B030FCP233701-1, 37mm plate, standard
B030FCP233601-1, 36mm plate, standard
B030FCP233501-1, 35mm plate, standard
B030FCP233401-1, 34mm plate, standard
B030FCP233301-1, 33mm plate, standard
B030FCP233201-1, 32mm plate, standard
B030FCP233101-1, 31mm plate, standard
B030FCP233001-1, 30mm plate, standard
B030FCP232901-1, 29mm plate, standard
B030FCP232801-1, 28mm plate, standard
B030FCP232701-1, 27mm plate, standard
B030FCP232601-1, 26mm plate, standard
B030FCP232501-1, 25mm plate, standard
B030FCP232401-1, 24mm plate, standard
B030FCP232301-1, 23mm plate, standard
B030FCP232201-1, 22mm plate, standard
B030FCP40502-2, 10mm plate, standard, 5mm spacer
B030FCP244602-1, 46mm plate, standard
B030FCP244502-1, 45mm plate, standard
B030FCP244402-1, 44mm plate, standard
B030FCP244302-1, 43mm plate, standard

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