8.7 mm X 80 mm iFuse TORQ TNT Implant

GUDID 00810055524242

8.7 mm X 80 mm iFuse TORQ TNT Implant

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, coated
Primary Device ID00810055524242
NIH Device Record Key69933ee8-5879-4ee0-88ac-20159817487a
Commercial Distribution StatusIn Commercial Distribution
Brand Name8.7 mm X 80 mm iFuse TORQ TNT Implant
Version Model Number870080
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
GS100810055524242 [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 Date2024-09-25
Device Publish Date2024-09-17

Devices Manufactured by Si-Bone Inc.

00810055524709 - iFuse TORQ TNT Instrument Tray2024-10-03 iFuse TORQ TNT Instrument Tray
00810055524716 - iFuse TORQ TNT Navigation Instrument Tray2024-10-03 iFuse TORQ TNT Navigation Instrument Tray
00810055523498 - Trocar Pin, 2.0 mm x 250 mm, TORQ TNT2024-09-25 Trocar Pin, 2.0 mm x 250 mm, TORQ TNT
00810055523504 - Trocar Pin, 2.0 mm x 330 mm, TORQ TNT2024-09-25 Trocar Pin, 2.0 mm x 330 mm, TORQ TNT
00810055523511 - Trocar Pin, 2.5 mm x 330 mm2024-09-25 Trocar Pin, 2.5 mm x 330 mm
00810055523528 - Drill Pin, 2.5 mm x 330 mm2024-09-25 Drill Pin, 2.5 mm x 330 mm
00810055523535 - Reverse Threaded Pin, 2.5 mm x 330 mm2024-09-25 Reverse Threaded Pin, 2.5 mm x 330 mm
00810055523542 - Trocar Pin, 2.5 mm x 450 mm2024-09-25 Trocar Pin, 2.5 mm x 450 mm

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