Primary Device ID | B030ORM175950 |
NIH Device Record Key | 87fa2c16-dd83-4376-9fef-4b09eb56f476 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ORTHROS MIS |
Version Model Number | ORM-1-7595 |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B030ORM175950 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
[B030ORM175950]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-20 |
Device Publish Date | 2024-05-10 |
B030ORM95C0 | Ø5.5mm Curved Rod 95mm Lg. |
B030ORM90C0 | Ø5.5mm Curved Rod 90mm Lg. |
B030ORM85C0 | Ø5.5mm Curved Rod 85mm Lg. |
B030ORM8595L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 95mm Lg. Long Tower |
B030ORM85950 | Ø8.5mm MIS Polyaxial Pedicle Screw, 95mm |
B030ORM8590L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 90mm Lg. Long Tower |
B030ORM85900 | Ø8.5mm MIS Polyaxial Pedicle Screw, 90mm |
B030ORM8585L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 85mm Lg. Long Tower |
B030ORM85850 | Ø8.5mm MIS Polyaxial Pedicle Screw, 85mm |
B030ORM8580L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 80mm Lg. Long Tower |
B030ORM85800 | Ø8.5mm MIS Polyaxial Pedicle Screw, 80mm |
B030ORM8575L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 75mm Lg. Long Tower |
B030ORM85750 | Ø8.5mm MIS Polyaxial Pedicle Screw, 75mm |
B030ORM8570L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 70mm Lg. Long Tower |
B030ORM85700 | Ø8.5mm MIS Polyaxial Pedicle Screw, 70mm |
B030ORM8565L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 65mm Lg. Long Tower |
B030ORM85650 | Ø8.5mm MIS Polyaxial Pedicle Screw, 65mm |
B030ORM8560L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 60mm Lg. Long Tower |
B030ORM85600 | Ø8.5mm MIS Polyaxial Pedicle Screw, 60mm |
B030ORM8555L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 55mm Lg. Long Tower |
B030ORM85550 | Ø8.5mm MIS Polyaxial Pedicle Screw, 55mm |
B030ORM8550L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 50mm Lg. Long Tower |
B030ORM85500 | Ø8.5mm MIS Polyaxial Pedicle Screw, 50mm |
B030ORM8545L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 45mm Lg. Long Tower |
B030ORM85450 | Ø8.5mm MIS Polyaxial Pedicle Screw, 45mm |
B030ORM8540L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 40mm Lg. Long Tower |
B030ORM85400 | Ø8.5mm MIS Polyaxial Pedicle Screw, 40mm |
B030ORM8535L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 35mm Lg. Long Tower |
B030ORM85350 | Ø8.5mm MIS Polyaxial Pedicle Screw, 35mm |
B030ORM8530L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 30mm Lg. Long Tower |
B030ORM85300 | Ø8.5mm MIS Polyaxial Pedicle Screw, 30mm |
B030ORM85110L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 110mm Lg. Long Tower |
B030ORM851100 | Ø8.5mm MIS Polyaxial Pedicle Screw, 110mm |
B030ORM85105L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 105mm Lg. Long Tower |
B030ORM851050 | Ø8.5mm MIS Polyaxial Pedicle Screw, 105mm |
B030ORM85100L0 | Ø8.5mm Cannulated MIS Polyaxial Pedicle Screw, 100mm Lg. Long Tower |
B030ORM851000 | Ø8.5mm MIS Polyaxial Pedicle Screw, 100mm |
B030ORM80C0 | Ø5.5mm Curved Rod 80mm Lg. |
B030ORM75C0 | Ø5.5mm Curved Rod 75mm Lg. |
B030ORM7595L0 | Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 95mm Lg. Long Tower |
B030ORM75950 | Ø7.5mm MIS Polyaxial Pedicle Screw, 95mm |
B030ORM7590L0 | Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 90mm Lg. Long Tower |
B030ORM75900 | Ø7.5mm MIS Polyaxial Pedicle Screw, 90mm |
B030ORM7585L0 | Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 85mm Lg. Long Tower |
B030ORM75850 | Ø7.5mm MIS Polyaxial Pedicle Screw, 85mm |
B030ORM7580L0 | Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 80mm Lg. Long Tower |
B030ORM75800 | Ø7.5mm MIS Polyaxial Pedicle Screw, 80mm |
B030ORM7575L0 | Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 75mm Lg. Long Tower |
B030ORM75750 | Ø7.5mm MIS Polyaxial Pedicle Screw, 75mm |
B030ORM7570L0 | Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 70mm Lg. Long Tower |