Siconus™ SI Joint Fixation System

GUDID B030SCL070400

Ø7mm Bone Screw, Cannulated, 40mm

CAMBER SPINE TECHNOLOGIES, LLC

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile
Primary Device IDB030SCL070400
NIH Device Record Keyb726c097-89a4-4f31-a93a-0e918ba4b9a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSiconus™ SI Joint Fixation System
Version Model NumberSCL-07-040
Company DUNS054205979
Company NameCAMBER SPINE TECHNOLOGIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com

Device Dimensions

Length40 Millimeter
Length40 Millimeter
Length40 Millimeter
Length40 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030SCL070400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B030SCL070400]

Moist Heat or Steam Sterilization


[B030SCL070400]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-05
Device Publish Date2017-02-03

On-Brand Devices [Siconus™ SI Joint Fixation System]

B030SCL110650Ø11mm Bone Screw, Cannulated, 65mm
B030SCL110600Ø11mm Bone Screw, Cannulated, 60mm
B030SCL110550Ø11mm Bone Screw, Cannulated, 55mm
B030SCL110500Ø11mm Bone Screw, Cannulated, 50mm
B030SCL110450Ø11mm Bone Screw, Cannulated, 45mm
B030SCL110400Ø11mm Bone Screw, Cannulated, 40mm
B030SCL110350Ø11mm Bone Screw, Cannulated, 35mm
B030SCL070700Ø7mm Bone Screw, Cannulated, 70mm
B030SCL070650Ø7mm Bone Screw, Cannulated, 65mm
B030SCL070600Ø7mm Bone Screw, Cannulated, 60mm
B030SCL070550Ø7mm Bone Screw, Cannulated, 55mm
B030SCL070500Ø7mm Bone Screw, Cannulated, 50mm
B030SCL070450Ø7mm Bone Screw, Cannulated, 45mm
B030SCL070400Ø7mm Bone Screw, Cannulated, 40mm
B030SCL070350Ø7mm Bone Screw, Cannulated, 35mm
B030SCL070300Ø7mm Bone Screw, Cannulated, 30mm

Trademark Results [Siconus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SICONUS
SICONUS
90614986 not registered Live/Pending
Camber Spine Technologies, LLC
2021-03-31

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