iFuse TORQ Implant System

GUDID 00810055520497

11.5 mm x 90 mm iFuse-TORQ, Lag

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, coated
Primary Device ID00810055520497
NIH Device Record Key00e48621-fd86-4ef6-a623-8731e662e645
Commercial Distribution StatusIn Commercial Distribution
Brand NameiFuse TORQ Implant System
Version Model Number11590LG
Company DUNS830127168
Company NameSi-Bone Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com
Phone855-884-3873
Emailinfo@si-bone.com

Device Dimensions

Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter
Length90 Millimeter
Outer Diameter11.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810055520497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-16
Device Publish Date2021-03-08

On-Brand Devices [iFuse TORQ Implant System]

0081005552073213.5 mm x 90 mm iFuse-TORQ, Lag
0081005552072513.5 mm x 85 mm iFuse-TORQ, Lag
0081005552071813.5 mm x 80 mm iFuse-TORQ, Lag
0081005552070113.5 mm x 75 mm iFuse-TORQ, Lag
0081005552069513.5 mm x 70 mm iFuse-TORQ, Lag
0081005552068813.5 mm x 65 mm iFuse-TORQ, Lag
0081005552067113.5 mm x 60 mm iFuse-TORQ, Lag
0081005552066413.5 mm x 55 mm iFuse-TORQ, Lag
0081005552065713.5 mm x 50 mm iFuse-TORQ, Lag
0081005552064013.5 mm x 45 mm iFuse-TORQ, Lag
0081005552063313.5 mm x 40 mm iFuse-TORQ, Lag
0081005552062613.5 mm x 90 mm iFuse-TORQ
0081005552061913.5 mm x 85 mm iFuse-TORQ
0081005552060213.5 mm x 80 mm iFuse-TORQ
0081005552059613.5 mm x 75 mm iFuse-TORQ
0081005552058913.5 mm x 70 mm iFuse-TORQ
0081005552057213.5 mm x 65 mm iFuse-TORQ
0081005552056513.5 mm x 60 mm iFuse-TORQ
0081005552055813.5 mm x 55 mm iFuse-TORQ
0081005552054113.5 mm x 50 mm iFuse-TORQ
0081005552053413.5 mm x 45 mm iFuse-TORQ
0081005552052713.5 mm x 40 mm iFuse-TORQ
0081005552051013.5 mm x 35 mm iFuse-TORQ
0081005552050313.5 mm x 30 mm iFuse-TORQ
0081005552049711.5 mm x 90 mm iFuse-TORQ, Lag
0081005552048011.5 mm x 85 mm iFuse-TORQ, Lag
0081005552047311.5 mm x 80 mm iFuse-TORQ, Lag
0081005552046611.5 mm x 75 mm iFuse-TORQ, Lag
0081005552045911.5 mm x 70 mm iFuse-TORQ, Lag
0081005552044211.5 mm x 65 mm iFuse-TORQ, Lag
0081005552043511.5 mm x 60 mm iFuse-TORQ, Lag
0081005552042811.5 mm x 55 mm iFuse-TORQ, Lag
0081005552041111.5 mm x 50 mm iFuse-TORQ, Lag
0081005552040411.5 mm x 45 mm iFuse-TORQ, Lag
0081005552039811.5 mm x 40 mm iFuse-TORQ, Lag
0081005552038111.5 mm x 90 mm iFuse-TORQ
0081005552037411.5 mm x 85 mm iFuse-TORQ
0081005552036711.5 mm x 80 mm iFuse-TORQ
0081005552035011.5 mm x 75 mm iFuse-TORQ
0081005552034311.5 mm x 70 mm iFuse-TORQ
0081005552033611.5 mm x 65 mm iFuse-TORQ
0081005552032911.5 mm x 60 mm iFuse-TORQ
0081005552031211.5 mm x 55 mm iFuse-TORQ
0081005552030511.5 mm x 50 mm iFuse-TORQ
0081005552029911.5 mm x 45 mm iFuse-TORQ
0081005552028211.5 mm x 40 mm iFuse-TORQ
0081005552027511.5 mm x 35 mm iFuse-TORQ
0081005552026811.5 mm x 30 mm iFuse-TORQ
0081005552025110.0 mm x 90 mm iFuse-TORQ, Lag
0081005552024410.0 mm x 85 mm iFuse-TORQ, Lag

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