ORTHROS Quarter Turn

GUDID B030OQT131320

Screw Head Positioner

CAMBER SPINE TECHNOLOGIES, LLC

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device IDB030OQT131320
NIH Device Record Key47b1eb8a-2c1c-42e2-bb8e-abea00829b58
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHROS Quarter Turn
Version Model NumberOQT-131-32
Company DUNS054205979
Company NameCAMBER SPINE TECHNOLOGIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030OQT131320 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

[B030OQT131320]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-03
Device Publish Date2023-10-26

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