SI-LUTION Sacroiliac Joint Fusion System

GUDID B648C6147050H0

Sacroiliac Screw, Headless, 7 x 50mm

CURITEVA, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Primary Device IDB648C6147050H0
NIH Device Record Key41e46551-145d-4a45-865d-9a2dd58cd02d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSI-LUTION Sacroiliac Joint Fusion System
Version Model NumberC614-7050-H
Company DUNS074575332
Company NameCURITEVA, INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com
Phone+1 (877) 928-7483
Emailsupport@curiteva.com

Device Dimensions

Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter
Outer Diameter7 Millimeter
Length50 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB648C6147050H0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

[B648C6147050H0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-31
Device Publish Date2023-03-23

On-Brand Devices [SI-LUTION Sacroiliac Joint Fusion System]

B648C61495SC0Stabilization Cap, Static, 9.5mm
B648C61495KC0Stabilization Cap, Kinetic, 9.5mm
B648C61495700Sacroiliac Screw, Fully Threaded, 9.5 x 70mm
B648C61495650Sacroiliac Screw, Fully Threaded, 9.5 x 65mm
B648C61495600Sacroiliac Screw, Fully Threaded, 9.5 x 60mm
B648C61495550Sacroiliac Screw, Fully Threaded, 9.5 x 55mm
B648C61495500Sacroiliac Screw, Fully Threaded, 9.5 x 50mm
B648C61495450Sacroiliac Screw, Fully Threaded, 9.5 x 45mm
B648C61495400Sacroiliac Screw, Fully Threaded, 9.5 x 40mm
B648C61495350Sacroiliac Screw, Fully Threaded, 9.5 x 35mm
B648C61495300Sacroiliac Screw, Fully Threaded, 9.5 x 30mm
B648C61470SC0Stabilization Cap, Static, 7mm
B648C61470KC0Stabilization Cap, Kinetic, 7mm
B648C61470700Sacroiliac Screw, Fully Threaded, 7 x 70mm
B648C61470650Sacroiliac Screw, Fully Threaded, 7 x 65mm
B648C61470600Sacroiliac Screw, Fully Threaded, 7 x 60mm
B648C61470550Sacroiliac Screw, Fully Threaded, 7 x 55mm
B648C61470500Sacroiliac Screw, Fully Threaded, 7 x 50mm
B648C61470450Sacroiliac Screw, Fully Threaded, 7 x 45mm
B648C61470400Sacroiliac Screw, Fully Threaded, 7 x 40mm
B648C61470350Sacroiliac Screw, Fully Threaded, 7 x 35mm
B648C61470300Sacroiliac Screw, Fully Threaded, 7 x 30mm
B648C61412SC0Stabilization Cap, Static, 12mm
B648C61412KC0Stabilization Cap, Kinetic, 12mm
B648C61412700Sacroiliac Screw, Fully Threaded, 12 x 70mm
B648C61412650Sacroiliac Screw, Fully Threaded, 12 x 65mm
B648C61412600Sacroiliac Screw, Fully Threaded, 12 x 60mm
B648C61412550Sacroiliac Screw, Fully Threaded, 12 x 55mm
B648C61412500Sacroiliac Screw, Fully Threaded, 12 x 50mm
B648C61412450Sacroiliac Screw, Fully Threaded, 12 x 45mm
B648C61412400Sacroiliac Screw, Fully Threaded, 12 x 40mm
B648C61412350Sacroiliac Screw, Fully Threaded, 12 x 35mm
B648C61412300Sacroiliac Screw, Fully Threaded, 12 x 30mm
B648C6149570H0Sacroiliac Screw, Headless, 9.5 x 70mm
B648C6149565H0Sacroiliac Screw, Headless, 9.5 x 65mm
B648C6149560H0Sacroiliac Screw, Headless, 9.5 x 60mm
B648C6149555H0Sacroiliac Screw, Headless, 9.5 x 55mm
B648C6149550H0Sacroiliac Screw, Headless, 9.5 x 50mm
B648C6149545H0Sacroiliac Screw, Headless, 9.5 x 45mm
B648C6149540H0Sacroiliac Screw, Headless, 9.5 x 40mm
B648C6149535H0Sacroiliac Screw, Headless, 9.5 x 35mm
B648C6149530H0Sacroiliac Screw, Headless, 9.5 x 30mm
B648C6147070H0Sacroiliac Screw, Headless, 7 x 70mm
B648C6147065H0Sacroiliac Screw, Headless, 7 x 65mm
B648C6147060H0Sacroiliac Screw, Headless, 7 x 60mm
B648C6147055H0Sacroiliac Screw, Headless, 7 x 55mm
B648C6147050H0Sacroiliac Screw, Headless, 7 x 50mm
B648C6147045H0Sacroiliac Screw, Headless, 7 x 45mm
B648C6147040H0Sacroiliac Screw, Headless, 7 x 40mm
B648C6147035H0Sacroiliac Screw, Headless, 7 x 35mm
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