ORTHROS Posterior Stabilization System

GUDID B030CP004021

Ø6.5mm Polyaxial Pedicle Screw, 65mm Lg.

CAMBER SPINE TECHNOLOGIES, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB030CP004021
NIH Device Record Key47d5f874-76a2-450a-8ccf-f878ac51c0c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHROS Posterior Stabilization System
Version Model NumberCP-004-21
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
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
HIBCCB030CP004021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


[B030CP004021]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-07
Device Publish Date2022-10-28

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B030EZO5020050 - Enza-O2024-07-30 8° Trial Caddy Body
B030EZO5020060 - Enza-O2024-07-30 15° Trial Caddy Body
B030EZO5030010 - Enza-O2024-07-30 8°, 26mm x 32mm Caddy Lid
B030EZO5030020 - Enza-O2024-07-30 8°, 30mm x 38mm Caddy Lid
B030EZO5030030 - Enza-O2024-07-30 15°, 26mm x 32mm Caddy Lid

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