Primary Device ID | B030OQT55350 |
NIH Device Record Key | 94559daf-9bc2-43bf-9231-6b6134b1fb0e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ORTHROS Quarter Turn |
Version Model Number | OQT-5535 |
Company DUNS | 054205979 |
Company Name | CAMBER SPINE TECHNOLOGIES, LLC |
Device Count | 1 |
DM Exempt | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B030OQT55350 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
[B030OQT55350]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-02 |
Device Publish Date | 2022-11-24 |
B030OQT75950 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 95mm |
B030OQT75900 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 90mm |
B030OQT75850 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 85mm |
B030OQT75800 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 80mm |
B030OQT75750 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 75mm |
B030OQT75700 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 70mm |
B030OQT75650 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 65mm |
B030OQT75600 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 60mm |
B030OQT75550 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 55mm |
B030OQT75500 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 50mm |
B030OQT75450 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 45mm |
B030OQT75400 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 40mm |
B030OQT75350 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 35mm |
B030OQT75300 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 30mm |
B030OQT751100 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 110mm |
B030OQT751050 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 105mm |
B030OQT751000 | Ø7.5mm Quarter Turn Polyaxial Pedicle Screw, 100mm |
B030OQT65650 | Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 65mm |
B030OQT65600 | Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 60mm |
B030OQT65550 | Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 55mm |
B030OQT65500 | Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 50mm |
B030OQT65450 | Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 45mm |
B030OQT65400 | Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 40mm |
B030OQT65350 | Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 35mm |
B030OQT65300 | Ø6.5mm Quarter Turn Polyaxial Pedicle Screw, 30mm |
B030OQT55550 | Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 55mm |
B030OQT55500 | Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 50mm |
B030OQT55450 | Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 45mm |
B030OQT55400 | Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 40mm |
B030OQT55350 | Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 35mm |
B030OQT55300 | Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 30mm |
B030OQT55250 | Ø5.5mm Quarter Turn Polyaxial Pedicle Screw, 25mm |
B030OQT45500 | Ø4.5mm Quarter Turn Polyaxial Pedicle Screw, 50mm |
B030OQT45450 | Ø4.5mm Quarter Turn Polyaxial Pedicle Screw, 45mm |
B030OQT45400 | Ø4.5mm Quarter TurnPolyaxial Pedicle Screw, 40mm |
B030OQT45350 | Ø4.5mm Quarter Turn Polyaxial Pedicle Screw, 35mm |
B030OQT45300 | Ø4.5mm Quarter Turn Polyaxial Pedicle Screw, 30mm |
B030OQT45250 | Ø4.5mm Quarter Turn Polyaxial Pedicle Screw, 25mm |
B030OQT002040 | Quarter Turn Locking Cap |
B030OQT132640 | Tower Reducer Outer Sleeve |
B030OQT132620 | Tower Reducer Insert |
B030OQT131320 | Screw Head Positioner |
B030OQT117530 | T20 Final Tightening Driver, 1/4" QC |
B030OQT117420 | QT Driver 2 of 2 |
B030OQT117410 | QT Driver 1 of 2 |
B030OQT132630 | Tower Reducer Reduction Nut |
B030OQT132520 | Tower Reducer, Socket Attachment, 1/4" QC |
B030OQT100560 | 5.5 N-M Final Tightening Handle, Torque Limiting |
B030OQT100550 | Ratcheting Palm Handle, 1/4" Quick Connect |