Primary Device ID | B030ORT7540C0 |
NIH Device Record Key | 53faa07c-68c0-4af8-bd86-442553a5d295 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Orthros |
Version Model Number | ORT-7540C |
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 | true |
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 | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com | |
Phone | 1-866-643-0739 |
customerservice@cambermedtech.com |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B030ORT7540C0 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
[B030ORT7540C0]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-02-05 |
Device Publish Date | 2019-01-22 |
B030ORT8595R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 95mm Lg. |
B030ORT8595CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 95mm Lg. |
B030ORT8595C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 95mm Lg. |
B030ORT85950 | Ø8.5mm Polyaxial Pedicle Screw, 95mm Lg. |
B030ORT8590R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 90mm Lg. |
B030ORT8590CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 90mm Lg. |
B030ORT8590C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 90mm Lg. |
B030ORT85900 | Ø8.5mm Polyaxial Pedicle Screw, 90mm Lg. |
B030ORT8585R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 85mm Lg. |
B030ORT8585CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 85mm Lg. |
B030ORT8585C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 85mm Lg. |
B030ORT85850 | Ø8.5mm Polyaxial Pedicle Screw, 85mm Lg. |
B030ORT8580R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 80mm Lg. |
B030ORT8580CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 80mm Lg. |
B030ORT8580C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 80mm Lg. |
B030ORT85800 | Ø8.5mm Polyaxial Pedicle Screw, 80mm Lg. |
B030ORT8575R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 75mm Lg. |
B030ORT8575CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 75mm Lg. |
B030ORT8575C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 75mm Lg. |
B030ORT85750 | Ø8.5mm Polyaxial Pedicle Screw, 75mm Lg. |
B030ORT8570R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 70mm Lg. |
B030ORT8570CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 70mm Lg. |
B030ORT8570C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 70mm Lg. |
B030ORT85700 | Ø8.5mm Polyaxial Pedicle Screw, 70mm Lg. |
B030ORT8565R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 65mm Lg. |
B030ORT8565CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 65mm Lg. |
B030ORT8565C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 65mm Lg. |
B030ORT85650 | Ø8.5mm Polyaxial Pedicle Screw, 65mm Lg. |
B030ORT8560R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 60mm Lg. |
B030ORT8560CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 60mm Lg. |
B030ORT8560C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 60mm Lg. |
B030ORT85600 | Ø8.5mm Polyaxial Pedicle Screw, 60mm Lg. |
B030ORT8555R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 55mm Lg. |
B030ORT8555CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 55mm Lg. |
B030ORT8555C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 55mm Lg. |
B030ORT85550 | Ø8.5mm Polyaxial Pedicle Screw, 55mm Lg. |
B030ORT8550R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 50mm Lg. |
B030ORT8550CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 50mm Lg. |
B030ORT8550C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 50mm Lg. |
B030ORT85500 | Ø8.5mm Polyaxial Pedicle Screw, 50mm Lg. |
B030ORT8545R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 45mm Lg. |
B030ORT8545CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 45mm Lg. |
B030ORT8545C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 45mm Lg. |
B030ORT85450 | Ø8.5mm Polyaxial Pedicle Screw, 45mm Lg. |
B030ORT8540R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 40mm Lg. |
B030ORT8540CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 40mm Lg. |
B030ORT8540C0 | Ø8.5mm Cannulated Polyaxial Pedicle Screw, 40mm Lg. |
B030ORT85400 | Ø8.5mm Polyaxial Pedicle Screw, 40mm Lg. |
B030ORT8535R0 | Ø8.5mm Polyaxial Reduction Pedicle Screw, 35mm Lg. |
B030ORT8535CR0 | Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 35mm Lg. |