Primary Device ID | B030SAZ5545FD0 |
NIH Device Record Key | 7e53556d-0130-4991-91ff-bb09f0505e30 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Alcantara Thoracolumbar Plating |
Version Model Number | SAZ-5545FD |
Catalog Number | NA |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B030SAZ5545FD0 [Primary] |
KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
[B030SAZ5545FD0]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-25 |
Device Publish Date | 2024-07-17 |
B030TLP424WL0 | 4-hole Windswept Sacral Plate, Left, 36mm |
B030TLP422WL0 | 4-hole Windswept Sacral Plate, Left, 34mm |
B030TLP420WL0 | 4-hole Windswept Sacral Plate, Left, 32mm |
B030SAZ5545FD0 | 5.5mm, Fixed Angle, Self-Drilling Bone Screw, 45mm |
B030SAZ5540FD0 | 5.5mm, Fixed Angle, Self-Drilling Bone Screw, 40mm |