iFuse TORQ Implant System-Driver Sleeve 2

GUDID 00855369008514

Driver Sleeve 2

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit Sacroiliac joint transarticular fixation/arthrodesis implantation kit
Primary Device ID00855369008514
NIH Device Record Key39d98f8f-360e-4cd7-a372-5a4e5aa32662
Commercial Distribution StatusIn Commercial Distribution
Brand NameiFuse TORQ Implant System-Driver Sleeve 2
Version Model Number400262
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 Usefalse
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

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 Identifiers

Device Issuing AgencyDevice ID
GS100855369008514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

[00855369008514]

Moist Heat or Steam Sterilization

Device Entry Metadata

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

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