ORTHROS Quarter Turn

GUDID B030OQT45500

Ø4.5mm Quarter Turn Polyaxial Pedicle Screw, 50mm

CAMBER SPINE TECHNOLOGIES, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB030OQT45500
NIH Device Record Key5f63f707-9afe-44c9-9137-094f52f151cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHROS Quarter Turn
Version Model NumberOQT-4550
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
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
HIBCCB030OQT45500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

[B030OQT45500]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-02
Device Publish Date2022-11-24

On-Brand Devices [ORTHROS Quarter Turn]

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B030OQT75900Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 90mm
B030OQT75850Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 85mm
B030OQT75800Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 80mm
B030OQT75750Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 75mm
B030OQT75700Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 70mm
B030OQT75650Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 65mm
B030OQT75600Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 60mm
B030OQT75550Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 55mm
B030OQT75500Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 50mm
B030OQT75450Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 45mm
B030OQT75400Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 40mm
B030OQT75350Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 35mm
B030OQT75300Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 30mm
B030OQT751100Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 110mm
B030OQT751050Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 105mm
B030OQT751000Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 100mm
B030OQT65650Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 65mm
B030OQT65600Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 60mm
B030OQT65550Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 55mm
B030OQT65500Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 50mm
B030OQT65450Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 45mm
B030OQT65400Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 40mm
B030OQT65350Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 35mm
B030OQT65300Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 30mm
B030OQT55550Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 55mm
B030OQT55500Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 50mm
B030OQT55450Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 45mm
B030OQT55400Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 40mm
B030OQT55350Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 35mm
B030OQT55300Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 30mm
B030OQT55250Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 25mm
B030OQT45500Ø4.5mm Quarter Turn Polyaxial Pedicle Screw, 50mm
B030OQT45450Ø4.5mm Quarter Turn Polyaxial Pedicle Screw, 45mm
B030OQT45400Ø4.5mm Quarter TurnPolyaxial Pedicle Screw, 40mm
B030OQT45350Ø4.5mm Quarter Turn Polyaxial Pedicle Screw, 35mm
B030OQT45300Ø4.5mm Quarter Turn Polyaxial Pedicle Screw, 30mm
B030OQT45250Ø4.5mm Quarter Turn Polyaxial Pedicle Screw, 25mm
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