Fuse Pedicle Screw System FZ-MC55110

GUDID B565FZMC551101

5.5 mm x 110 mm MIS Curved Rod

CPM MEDICAL CONSULTANTS, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB565FZMC551101
NIH Device Record Key518ba972-0527-4bbf-804f-f99cbef04c24
Commercial Distribution StatusIn Commercial Distribution
Brand NameFuse Pedicle Screw System
Version Model NumberRev C
Catalog NumberFZ-MC55110
Company DUNS017138000
Company NameCPM MEDICAL CONSULTANTS, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx
Phone972-331-5860
Emailxx@xx.xx

Device Dimensions

Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter
Outer Diameter5.5 Millimeter
Length110 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB565FZMC551101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


[B565FZMC551101]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-06
Device Publish Date2020-06-26

On-Brand Devices [Fuse Pedicle Screw System]

B565FZTC6555CA16.5 mm x 55 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC6550CA16.5 mm x 50 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC6545CA16.5 mm x 45 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC6540CA16.5 mm x 40 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC6535CA16.5 mm x 35 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC6530CA16.5 mm x 30 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC5550CA15.5 mm x 50 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC5545CA15.5 mm x 45 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC5540CA15.5 mm x 40 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC5535CA15.5 mm x 35 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZSC1001Set Caps
B565FZMN7555A17.5mm x 55mm MID TOP Screw Non-Cannulated
B565FZMN7550A17.5mm x 50mm MID TOP Screw Non-Cannulated
B565FZMN7545A17.5mm x 45mm MID TOP Screw Non-Cannulated
B565FZMN7540A17.5mm x 40mm MID TOP Screw Non-Cannulated
B565FZMN7535A17.5mm x 35mm MID TOP Screw Non-Cannulated
B565FZMN7530A17.5mm x 30mm MID TOP Screw Non-Cannulated
B565FZMN6555A16.5mm x 55mm MID TOP Screw Non-Cannulated
B565FZMN6550A16.5mm x 50mm MID TOP Screw Non-Cannulated
B565FZMN6545A16.5 mm x 45 mm MID TOP Screw Non-Cannulated
B565FZMN6540A16.5 mm x 40 mm MID TOP Screw Non-Cannulated
B565FZMN6535A16.5 mm x 35 mm MID TOP Screw Non-Cannulated
B565FZMN6530A16.5 mm x 30 mm MID TOP Screw Non-Cannulated
B565FZMN5550A15.5 mm x 50 mm MID TOP Screw Non-Cannulated
B565FZMN5545A15.5 mm x 45 mm MID TOP Screw Non-Cannulated
B565FZMN5540A15.5 mm x 40 mm MID TOP Screw Non-Cannulated
B565FZMN5535A15.5 mm x 35 mm MID TOP Screw Non-Cannulated
B565FZMN5530A15.5 mm x 30 mm MID TOP Screw Non-Cannulated
B565FZMN5525A15.5 mm x 25 mm MID TOP Screw Non-Cannulated
B565FZMC559515.5 mm x 95 mm MIS Curved Rod
B565FZMC559015.5 mm x 90 mm MIS Curved Rod
B565FZMC558515.5 mm x 85 mm MIS Curved Rod
B565FZMC558015.5 mm x 80 mm MIS Curved Rod
B565FZMC557515.5 mm x 75 mm MIS Curved Rod
B565FZMC557015.5 mm x 70 mm MIS Curved Rod
B565FZMC556515.5 mm x 65 mm MIS Curved Rod
B565FZMC556015.5 mm x 60 mm MIS Curved Rod
B565FZMC555515.5 mm x 55 mm MIS Curved Rod
B565FZMC555015.5 mm x 50 mm MIS Curved Rod
B565FZMC554515.5 mm x 45 mm MIS Curved Rod
B565FZMC554015.5 mm x 40 mm MIS Curved Rod
B565FZMC5515015.5 mm x 150 mm MIS Curved Rod
B565FZMC5514015.5 mm x 140 mm MIS Curved Rod
B565FZMC5513015.5 mm x 130 mm MIS Curved Rod
B565FZMC5512015.5 mm x 120 mm MIS Curved Rod
B565FZMC5511015.5 mm x 110 mm MIS Curved Rod
B565FZMC5510015.5 mm x 100 mm MIS Curved Rod
B565FZLN7555CA17.5 mm x 55 mm Low-Top Polyaxial Pedicle Screw Cannulated
B565FZLN7550CA17.5 mm x 50 mm Low-Top Polyaxial Pedicle Screw Cannulated
B565FZLN7545CA17.5 mm x 45 mm Low-Top Polyaxial Pedicle Screw Cannulated

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