ORTHROS Open NA

GUDID B030ORT175750

Ø7.5mm Polyaxial Screw, Orthros Upgrade, 75mm

CAMBER SPINE TECHNOLOGIES, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB030ORT175750
NIH Device Record Keydce99bd2-62d3-4315-9815-a64ba69e6216
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHROS Open
Version Model NumberORT-1-7575
Catalog NumberNA
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 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
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
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
HIBCCB030ORT175750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

[B030ORT175750]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-16
Device Publish Date2024-05-08

On-Brand Devices [ORTHROS Open]

B030ORT165950Ø6.5mm Polyaxial Screw, Orthros Upgrade, 95mm
B030ORT165900Ø6.5mm Polyaxial Screw, Orthros Upgrade, 90mm
B030ORT165850Ø6.5mm Polyaxial Screw, Orthros Upgrade, 85mm
B030ORT165800Ø6.5mm Polyaxial Screw, Orthros Upgrade, 80mm
B030ORT165750Ø6.5mm Polyaxial Screw, Orthros Upgrade, 75mm
B030ORT165700Ø6.5mm Polyaxial Screw, Orthros Upgrade, 70mm
B030ORT165650Ø6.5mm Polyaxial Screw, Orthros Upgrade, 65mm
B030ORT165600Ø6.5mm Polyaxial Screw, Orthros Upgrade, 60mm
B030ORT165550Ø6.5mm Polyaxial Screw, Orthros Upgrade, 55mm
B030ORT165500Ø6.5mm Polyaxial Screw, Orthros Upgrade, 50mm
B030ORT165450Ø6.5mm Polyaxial Screw, Orthros Upgrade, 45mm
B030ORT165400Ø6.5mm Polyaxial Screw, Orthros Upgrade, 40mm
B030ORT165350Ø6.5mm Polyaxial Screw, Orthros Upgrade, 35mm
B030ORT165300Ø6.5mm Polyaxial Screw, Orthros Upgrade, 30mm
B030ORT165250Ø6.5mm Polyaxial Screw, Orthros Upgrade, 25mm
B030ORT1651100Ø6.5mm Polyaxial Screw, Orthros Upgrade, 110mm
B030ORT1651050Ø6.5mm Polyaxial Screw, Orthros Upgrade, 105mm
B030ORT1651000Ø6.5mm Polyaxial Screw, Orthros Upgrade, 100mm
B030ORT155800Ø5.5mm Polyaxial Screw, Orthros Upgrade, 80mm
B030ORT155750Ø5.5mm Polyaxial Screw, Orthros Upgrade, 75mm
B030ORT155700Ø5.5mm Polyaxial Screw, Orthros Upgrade, 70mm
B030ORT155650Ø5.5mm Polyaxial Screw, Orthros Upgrade, 65mm
B030ORT155600Ø5.5mm Polyaxial Screw, Orthros Upgrade, 60mm
B030ORT155550Ø5.5mm Polyaxial Screw, Orthros Upgrade, 55mm
B030ORT155500Ø5.5mm Polyaxial Screw, Orthros Upgrade, 50mm
B030ORT155450Ø5.5mm Polyaxial Screw, Orthros Upgrade, 45mm
B030ORT155400Ø5.5mm Polyaxial Screw, Orthros Upgrade, 40mm
B030ORT155350Ø5.5mm Polyaxial Screw, Orthros Upgrade, 35mm.
B030ORT155300Ø5.5mm Polyaxially Screw, Orthros Upgrade, 30mm
B030ORT155250Ø5.5mm Polyaxial Screw, Orthros Upgrade, 25mm
B030ORT185950Ø8.5mm Polyaxial Screw, Orthros Upgrade, 95mm
B030ORT185900Ø8.5mm Polyaxial Screw, Orthros Upgrade, 90mm
B030ORT185850Ø8.5mm Polyaxial Screw, Orthros Upgrade, 85mm
B030ORT185800Ø8.5mm Polyaxial Screw, Orthros Upgrade, 80mm
B030ORT185750Ø8.5mm Polyaxial Screw, Orthros Upgrade, 75mm
B030ORT185700Ø8.5mm Polyaxial Screw, Orthros Upgrade, 70mm
B030ORT185650Ø8.5mm Polyaxial Screw, Orthros Upgrade, 65mm
B030ORT185600Ø8.5mm Polyaxial Screw, Orthros Upgrade, 60mm
B030ORT185550Ø8.5mm Polyaxial Screw, Orthros Upgrade, 55mm
B030ORT185500Ø8.5mm Polyaxial Screw, Orthros Upgrade, 50mm
B030ORT185450Ø8.5mm Polyaxial Screw, Orthros Upgrade, 45mm
B030ORT185400Ø8.5mm Polyaxial Screw, Orthros Upgrade, 40mm
B030ORT185350Ø8.5mm Polyaxial Screw, Orthros Upgrade, 35mm
B030ORT185300Ø8.5mm Polyaxial Screw, Orthros Upgrade, 30mm
B030ORT185250Ø8.5mm Polyaxial Screw, Orthros Upgrade, 25mm
B030ORT1851100Ø8.5mm Polyaxial Screw, Orthros Upgrade, 110mm
B030ORT1851050Ø8.5mm Polyaxial Screw, Orthros Upgrade, 105mm
B030ORT1851000Ø8.5mm Polyaxial Screw, Orthros Upgrade, 100mm
B030ORT175950Ø7.5mm Polyaxial Screw, Orthros Upgrade, 95mm
B030ORT175900Ø7.5mm Polyaxial Screw, Orthros Upgrade, 90mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.