Fuse Pedicle Screw System FZ-LN6545A

GUDID B565FZLN6545A1

6.5 mm x 45 mm Low-Top Polyaxial Pedicle Screw

CPM MEDICAL CONSULTANTS, LLC

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	B565FZLN6545A1
NIH Device Record Key	13846a59-429c-45e1-8f18-3f97b031714c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Fuse Pedicle Screw System
Version Model Number	Rev C
Catalog Number	FZ-LN6545A
Company DUNS	017138000
Company Name	CPM MEDICAL CONSULTANTS, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx
Phone	972-331-5860
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B565FZLN6545A1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K182283

FDA Product Code

NKB	Thoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

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Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-05-11
Device Publish Date	2021-05-03

On-Brand Devices [Fuse Pedicle Screw System ]

B565FZTC6555CA1	6.5 mm x 55 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC6550CA1	6.5 mm x 50 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC6545CA1	6.5 mm x 45 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC6540CA1	6.5 mm x 40 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC6535CA1	6.5 mm x 35 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC6530CA1	6.5 mm x 30 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC5550CA1	5.5 mm x 50 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC5545CA1	5.5 mm x 45 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC5540CA1	5.5 mm x 40 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZTC5535CA1	5.5 mm x 35 mm Tall Cannulated Polyaxial Pedicle Screw
B565FZSC1001	Set Caps
B565FZMN7555A1	7.5mm x 55mm MID TOP Screw Non-Cannulated
B565FZMN7550A1	7.5mm x 50mm MID TOP Screw Non-Cannulated
B565FZMN7545A1	7.5mm x 45mm MID TOP Screw Non-Cannulated
B565FZMN7540A1	7.5mm x 40mm MID TOP Screw Non-Cannulated
B565FZMN7535A1	7.5mm x 35mm MID TOP Screw Non-Cannulated
B565FZMN7530A1	7.5mm x 30mm MID TOP Screw Non-Cannulated
B565FZMN6555A1	6.5mm x 55mm MID TOP Screw Non-Cannulated
B565FZMN6550A1	6.5mm x 50mm MID TOP Screw Non-Cannulated
B565FZMN6545A1	6.5 mm x 45 mm MID TOP Screw Non-Cannulated
B565FZMN6540A1	6.5 mm x 40 mm MID TOP Screw Non-Cannulated
B565FZMN6535A1	6.5 mm x 35 mm MID TOP Screw Non-Cannulated
B565FZMN6530A1	6.5 mm x 30 mm MID TOP Screw Non-Cannulated
B565FZMN5550A1	5.5 mm x 50 mm MID TOP Screw Non-Cannulated
B565FZMN5545A1	5.5 mm x 45 mm MID TOP Screw Non-Cannulated
B565FZMN5540A1	5.5 mm x 40 mm MID TOP Screw Non-Cannulated
B565FZMN5535A1	5.5 mm x 35 mm MID TOP Screw Non-Cannulated
B565FZMN5530A1	5.5 mm x 30 mm MID TOP Screw Non-Cannulated
B565FZMN5525A1	5.5 mm x 25 mm MID TOP Screw Non-Cannulated
B565FZMC55951	5.5 mm x 95 mm MIS Curved Rod
B565FZMC55901	5.5 mm x 90 mm MIS Curved Rod
B565FZMC55851	5.5 mm x 85 mm MIS Curved Rod
B565FZMC55801	5.5 mm x 80 mm MIS Curved Rod
B565FZMC55751	5.5 mm x 75 mm MIS Curved Rod
B565FZMC55701	5.5 mm x 70 mm MIS Curved Rod
B565FZMC55651	5.5 mm x 65 mm MIS Curved Rod
B565FZMC55601	5.5 mm x 60 mm MIS Curved Rod
B565FZMC55551	5.5 mm x 55 mm MIS Curved Rod
B565FZMC55501	5.5 mm x 50 mm MIS Curved Rod
B565FZMC55451	5.5 mm x 45 mm MIS Curved Rod
B565FZMC55401	5.5 mm x 40 mm MIS Curved Rod
B565FZMC551501	5.5 mm x 150 mm MIS Curved Rod
B565FZMC551401	5.5 mm x 140 mm MIS Curved Rod
B565FZMC551301	5.5 mm x 130 mm MIS Curved Rod
B565FZMC551201	5.5 mm x 120 mm MIS Curved Rod
B565FZMC551101	5.5 mm x 110 mm MIS Curved Rod
B565FZMC551001	5.5 mm x 100 mm MIS Curved Rod
B565FZLN7555CA1	7.5 mm x 55 mm Low-Top Polyaxial Pedicle Screw Cannulated
B565FZLN7550CA1	7.5 mm x 50 mm Low-Top Polyaxial Pedicle Screw Cannulated
B565FZLN7545CA1	7.5 mm x 45 mm Low-Top Polyaxial Pedicle Screw Cannulated

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