ALTIVO Anterior Cervical Fixation System

GUDID B030FCP2337E0

1-1, 37mm plate, extended

CAMBER SPINE TECHNOLOGIES, LLC

Spinal fixation plate, non-bioabsorbable
Primary Device IDB030FCP2337E0
NIH Device Record Key4057d0de-4997-41d2-bcee-2c793ed5943c
Commercial Distribution Discontinuation2023-01-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NameALTIVO Anterior Cervical Fixation System
Version Model NumberFCP-2337E
Company DUNS054205979
Company NameCAMBER SPINE TECHNOLOGIES, LLC
Device Count1
DM Exempttrue
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 Datefalse
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(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com
Phone+1(484) 427-7060
Emailquality@cambermedtech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030FCP2337E0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030FCP2337E0]

Moist Heat or Steam Sterilization

[B030FCP2337E0]

Moist Heat or Steam Sterilization

[B030FCP2337E0]

Moist Heat or Steam Sterilization

[B030FCP2337E0]

Moist Heat or Steam Sterilization

[B030FCP2337E0]

Moist Heat or Steam Sterilization

[B030FCP2337E0]

Moist Heat or Steam Sterilization

[B030FCP2337E0]

Moist Heat or Steam Sterilization

[B030FCP2337E0]

Moist Heat or Steam Sterilization

[B030FCP2337E0]

Moist Heat or Steam Sterilization

[B030FCP2337E0]

Moist Heat or Steam Sterilization

[B030FCP2337E0]

Moist Heat or Steam Sterilization

[B030FCP2337E0]

Moist Heat or Steam Sterilization

[B030FCP2337E0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2022-11-01

On-Brand Devices [ALTIVO Anterior Cervical Fixation System]

B030FCP50300202-2 Assembly Block Lid, FORTICO System
B030FCP50200202-2 Assembly Block Base, FORTICO System
B030FCP412E02-2, 17mm plate, extended, 12mm spacer
B030FCP411E02-2, 16mm plate, extended, 11mm spacer
B030FCP410E02-2, 15mm plate, extended, 10mm spacer
B030FCP409E02-2, 14mm plate, extended, 9mm spacer
B030FCP408E02-2, 13mm plate, extended, 8mm spacer
B030FCP407E02-2, 12mm plate, extended, 7mm spacer
B030FCP406E02-2, 11mm plate, extended, 6mm spacer
B030FCP405E02-2, 10mm plate, extended, 5mm spacer
B030FCP3065M0Ø3.0, center screw, 6.5mm
B030FCP3045M0Ø3.0, center screw, 4.5mm
B030FCP2546E02-2, 46mm plate, extended
B030FCP2545E02-2, 45mm plate, extended
B030FCP2544E02-2, 44mm plate, extended
B030FCP2543E02-2, 43mm plate, extended
B030FCP2542E02-2, 42mm plate, extended
B030FCP2541E02-2, 41mm plate, extended
B030FCP2540E02-2, 40mm plate, extended
B030FCP2539E02-2, 39mm plate, extended
B030FCP2538E02-2, 38mm plate, extended
B030FCP2537E02-2, 37mm plate, extended
B030FCP2536E02-2, 36mm plate, extended
B030FCP2535E02-2, 35mm plate, extended
B030FCP2534E02-2, 34mm plate, extended
B030FCP2533E02-2, 33mm plate, extended
B030FCP2532E02-2, 32mm plate, extended
B030FCP2531E02-2, 31mm plate, extended
B030FCP2530E02-2, 30mm plate, extended
B030FCP2529E02-2, 29mm plate, extended
B030FCP2528E02-2, 28mm plate, extended
B030FCP2527E02-2, 27mm plate, extended
B030FCP2526E02-2, 26mm plate, extended
B030FCP2525E02-2, 25mm plate, extended
B030FCP2524E02-2, 24mm plate, extended
B030FCP2523E02-2, 23mm plate, extended
B030FCP2522E02-2, 22mm plate, extended
B030FCP2521E02-2, 21mm plate, extended
B030FCP2520E02-2, 20mm plate, extended
B030FCP2519E02-2, 19mm plate, extended
B030FCP2446E02-1, 46mm plate, extended
B030FCP2445E02-1, 45mm plate, extended
B030FCP2444E02-1, 44mm plate, extended
B030FCP2443E02-1, 43mm plate, extended
B030FCP2442E02-1, 42mm plate, extended
B030FCP2441E02-1, 41mm plate, extended
B030FCP2440E02-1, 40mm plate, extended
B030FCP2439E02-1, 39mm plate, extended
B030FCP2438E02-1, 38mm plate, extended
B030FCP2437E02-1, 37mm plate, extended
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