iFuse TORQ Implant System-10.75 mm Navigation Tap, Cannulated

GUDID 00855369008583

10.75 mm Navigation Tap, Cannulated

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 ID00855369008583
NIH Device Record Key104573dd-d072-444c-9f69-90aff9c0408b
Commercial Distribution StatusIn Commercial Distribution
Brand NameiFuse TORQ Implant System-10.75 mm Navigation Tap, Cannulated
Version Model Number501124-1075
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
GS100855369008583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

Moist Heat or Steam Sterilization

[00855369008583]

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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