8.7 mm X 120 mm iFuse TORQ TNT Implant

GUDID 00810055524327

8.7 mm X 120 mm iFuse TORQ TNT Implant

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, coated
Primary Device ID00810055524327
NIH Device Record Key36e65c9a-eb74-4d60-8f07-48f969876486
Commercial Distribution StatusIn Commercial Distribution
Brand Name8.7 mm X 120 mm iFuse TORQ TNT Implant
Version Model Number870120
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810055524327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-25
Device Publish Date2024-09-17

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