iFuse Granite Implant System

GUDID 00810055521487

11.5 mm x 50 mm iFuse Bedrock Granite Implant

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated
Primary Device ID00810055521487
NIH Device Record Key38f4b2ce-d486-407b-9973-463f414a8c0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameiFuse Granite Implant System
Version Model Number115050BG
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

Device Dimensions

Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter
Length50 Millimeter
Outer Diameter11.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810055521487 [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 Date2022-06-08
Device Publish Date2022-05-31

On-Brand Devices [iFuse Granite Implant System]

00855369008705Guidewire Driver
00810055522149In-Line Handle, Pinned
00810055522132T-Handle, Pinned
00810055522088Bedrock Granite, Set Screw
00810055522071Bedrock Granite Instrument Set, MIS
00810055522064Bedrock Granite Instrument Set, Open
0081005552194413.5 mm x 120 mm iFuse Bedrock Granite Implant
0081005552193713.5 mm x 115 mm iFuse Bedrock Granite Implant
0081005552192013.5 mm x 110 mm iFuse Bedrock Granite Implant
0081005552191313.5 mm x 105 mm iFuse Bedrock Granite Implant
0081005552190613.5 mm x 100 mm iFuse Bedrock Granite Implant
0081005552189013.5 mm x 95 mm iFuse Bedrock Granite Implant
0081005552188313.5 mm x 90 mm iFuse Bedrock Granite Implant
0081005552187613.5 mm x 85 mm iFuse Bedrock Granite Implant
0081005552186913.5 mm x 80 mm iFuse Bedrock Granite Implant
0081005552185213.5 mm x 75 mm iFuse Bedrock Granite Implant
0081005552184513.5 mm x 70 mm iFuse Bedrock Granite Implant
0081005552183813.5 mm x 65 mm iFuse Bedrock Granite Implant
0081005552182113.5 mm x 60 mm iFuse Bedrock Granite Implant
0081005552181413.5 mm x 55 mm iFuse Bedrock Granite Implant
0081005552180713.5 mm x 50 mm iFuse Bedrock Granite Implant
0081005552179113.5 mm x 45 mm iFuse Bedrock Granite Implant
0081005552178412.5 mm x 120 mm iFuse Bedrock Granite Implant
0081005552177712.5 mm x 115 mm iFuse Bedrock Granite Implant
0081005552176012.5 mm x 110 mm iFuse Bedrock Granite Implant
0081005552175312.5 mm x 105 mm iFuse Bedrock Granite Implant
0081005552174612.5 mm x 100 mm iFuse Bedrock Granite Implant
0081005552173912.5 mm x 95 mm iFuse Bedrock Granite Implant
0081005552172212.5 mm x 90 mm iFuse Bedrock Granite Implant
0081005552171512.5 mm x 85 mm iFuse Bedrock Granite Implant
0081005552170812.5 mm x 80 mm iFuse Bedrock Granite Implant
0081005552169212.5 mm x 75 mm iFuse Bedrock Granite Implant
0081005552168512.5 mm x 70 mm iFuse Bedrock Granite Implant
0081005552167812.5 mm x 65 mm iFuse Bedrock Granite Implant
0081005552166112.5 mm x 60 mm iFuse Bedrock Granite Implant
0081005552165412.5 mm x 55 mm iFuse Bedrock Granite Implant
0081005552164712.5 mm x 50 mm iFuse Bedrock Granite Implant
0081005552163012.5 mm x 45 mm iFuse Bedrock Granite Implant
0081005552162311.5 mm x 120 mm iFuse Bedrock Granite Implant
0081005552161611.5 mm x 115 mm iFuse Bedrock Granite Implant
0081005552160911.5 mm x 110 mm iFuse Bedrock Granite Implant
0081005552159311.5 mm x 105 mm iFuse Bedrock Granite Implant
0081005552158611.5 mm x 100 mm iFuse Bedrock Granite Implant
0081005552157911.5 mm x 95 mm iFuse Bedrock Granite Implant
0081005552156211.5 mm x 90 mm iFuse Bedrock Granite Implant
0081005552155511.5 mm x 85 mm iFuse Bedrock Granite Implant
0081005552154811.5 mm x 80 mm iFuse Bedrock Granite Implant
0081005552153111.5 mm x 75 mm iFuse Bedrock Granite Implant
0081005552152411.5 mm x 70 mm iFuse Bedrock Granite Implant
0081005552151711.5 mm x 65 mm iFuse Bedrock Granite Implant

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