ORTHROS MIS NA

GUDID B030ORM165450

ORTHROS DUAL THREAD Ø6.5 MIS Screw, 45mm

CAMBER SPINE TECHNOLOGIES, LLC

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB030ORM165450
NIH Device Record Key3c9932c1-ef36-453b-8398-e8a83c3acc16
Commercial Distribution StatusIn Commercial Distribution
Brand NameORTHROS MIS
Version Model NumberORM-1-6545
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
Phone+1(484) 427-7060
Emailquality@cambermedtech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030ORM165450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

[B030ORM165450]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-17
Device Publish Date2024-05-09

On-Brand Devices [ORTHROS MIS]

B030ORM95C0Ø5.5mm Curved Rod 95mm Lg.
B030ORM90C0Ø5.5mm Curved Rod 90mm Lg.
B030ORM85C0Ø5.5mm Curved Rod 85mm Lg.
B030ORM8595L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 95mm Lg. Long Tower
B030ORM85950Ø8.5mm MIS Polyaxial Pedicle Screw, 95mm
B030ORM8590L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 90mm Lg. Long Tower
B030ORM85900Ø8.5mm MIS Polyaxial Pedicle Screw, 90mm
B030ORM8585L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 85mm Lg. Long Tower
B030ORM85850Ø8.5mm MIS Polyaxial Pedicle Screw, 85mm
B030ORM8580L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 80mm Lg. Long Tower
B030ORM85800Ø8.5mm MIS Polyaxial Pedicle Screw, 80mm
B030ORM8575L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 75mm Lg. Long Tower
B030ORM85750Ø8.5mm MIS Polyaxial Pedicle Screw, 75mm
B030ORM8570L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 70mm Lg. Long Tower
B030ORM85700Ø8.5mm MIS Polyaxial Pedicle Screw, 70mm
B030ORM8565L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 65mm Lg. Long Tower
B030ORM85650Ø8.5mm MIS Polyaxial Pedicle Screw, 65mm
B030ORM8560L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 60mm Lg. Long Tower
B030ORM85600Ø8.5mm MIS Polyaxial Pedicle Screw, 60mm
B030ORM8555L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 55mm Lg. Long Tower
B030ORM85550Ø8.5mm MIS Polyaxial Pedicle Screw, 55mm
B030ORM8550L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 50mm Lg. Long Tower
B030ORM85500Ø8.5mm MIS Polyaxial Pedicle Screw, 50mm
B030ORM8545L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 45mm Lg. Long Tower
B030ORM85450Ø8.5mm MIS Polyaxial Pedicle Screw, 45mm
B030ORM8540L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 40mm Lg. Long Tower
B030ORM85400Ø8.5mm MIS Polyaxial Pedicle Screw, 40mm
B030ORM8535L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 35mm Lg. Long Tower
B030ORM85350Ø8.5mm MIS Polyaxial Pedicle Screw, 35mm
B030ORM8530L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 30mm Lg. Long Tower
B030ORM85300Ø8.5mm MIS Polyaxial Pedicle Screw, 30mm
B030ORM85110L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 110mm Lg. Long Tower
B030ORM851100Ø8.5mm MIS Polyaxial Pedicle Screw, 110mm
B030ORM85105L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 105mm Lg. Long Tower
B030ORM851050Ø8.5mm MIS Polyaxial Pedicle Screw, 105mm
B030ORM85100L0Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 100mm Lg. Long Tower
B030ORM851000Ø8.5mm MIS Polyaxial Pedicle Screw, 100mm
B030ORM80C0Ø5.5mm Curved Rod 80mm Lg.
B030ORM75C0Ø5.5mm Curved Rod 75mm Lg.
B030ORM7595L0Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 95mm Lg. Long Tower
B030ORM75950Ø7.5mm MIS Polyaxial Pedicle Screw, 95mm
B030ORM7590L0Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 90mm Lg. Long Tower
B030ORM75900Ø7.5mm MIS Polyaxial Pedicle Screw, 90mm
B030ORM7585L0Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 85mm Lg. Long Tower
B030ORM75850Ø7.5mm MIS Polyaxial Pedicle Screw, 85mm
B030ORM7580L0Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 80mm Lg. Long Tower
B030ORM75800Ø7.5mm MIS Polyaxial Pedicle Screw, 80mm
B030ORM7575L0Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 75mm Lg. Long Tower
B030ORM75750Ø7.5mm MIS Polyaxial Pedicle Screw, 75mm
B030ORM7570L0Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 70mm Lg. Long Tower
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