Primary Device ID | B030ORT165350 |
NIH Device Record Key | 79d73dd5-3814-4581-bfa1-410df648cf26 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ORTHROS Open |
Version Model Number | ORT-1-6535 |
Catalog Number | NA |
Company DUNS | 054205979 |
Company Name | CAMBER SPINE TECHNOLOGIES, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com | |
Phone | +1(484) 427-7060 |
quality@cambermedtech.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B030ORT165350 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
[B030ORT165350]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-15 |
Device Publish Date | 2024-05-07 |
B030ORT165950 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 95mm |
B030ORT165900 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 90mm |
B030ORT165850 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 85mm |
B030ORT165800 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 80mm |
B030ORT165750 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 75mm |
B030ORT165700 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 70mm |
B030ORT165650 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 65mm |
B030ORT165600 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 60mm |
B030ORT165550 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 55mm |
B030ORT165500 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 50mm |
B030ORT165450 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 45mm |
B030ORT165400 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 40mm |
B030ORT165350 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 35mm |
B030ORT165300 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 30mm |
B030ORT165250 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 25mm |
B030ORT1651100 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 110mm |
B030ORT1651050 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 105mm |
B030ORT1651000 | Ø6.5mm Polyaxial Screw, Orthros Upgrade, 100mm |
B030ORT155800 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 80mm |
B030ORT155750 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 75mm |
B030ORT155700 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 70mm |
B030ORT155650 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 65mm |
B030ORT155600 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 60mm |
B030ORT155550 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 55mm |
B030ORT155500 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 50mm |
B030ORT155450 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 45mm |
B030ORT155400 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 40mm |
B030ORT155350 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 35mm. |
B030ORT155300 | Ø5.5mm Polyaxially Screw, Orthros Upgrade, 30mm |
B030ORT155250 | Ø5.5mm Polyaxial Screw, Orthros Upgrade, 25mm |
B030ORT185950 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 95mm |
B030ORT185900 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 90mm |
B030ORT185850 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 85mm |
B030ORT185800 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 80mm |
B030ORT185750 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 75mm |
B030ORT185700 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 70mm |
B030ORT185650 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 65mm |
B030ORT185600 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 60mm |
B030ORT185550 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 55mm |
B030ORT185500 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 50mm |
B030ORT185450 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 45mm |
B030ORT185400 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 40mm |
B030ORT185350 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 35mm |
B030ORT185300 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 30mm |
B030ORT185250 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 25mm |
B030ORT1851100 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 110mm |
B030ORT1851050 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 105mm |
B030ORT1851000 | Ø8.5mm Polyaxial Screw, Orthros Upgrade, 100mm |
B030ORT175950 | Ø7.5mm Polyaxial Screw, Orthros Upgrade, 95mm |
B030ORT175900 | Ø7.5mm Polyaxial Screw, Orthros Upgrade, 90mm |