FDA.report

iFuse Granite-Closed Head Implant System

Primary DI
00810055522637
Brand
iFuse Granite-Closed Head Implant System
Company
Si-Bone Inc.
Model
115045CH
Device description
11.5mm x 45mm iFuse-Granite Closed Head Implant
Published
2023-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OURSacroiliac Joint Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810055522637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055522637008100555226378100555226370810055522637

GMDN Terms

TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implant, coatedAn implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of metal [e.g., titanium (Ti)] with a porous plasma spray coating, and typically in the form of a cylinder or rod, possibly with a triangular cross-section. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.

Device Sizes

TypeValueUnit
Length45Millimeter
Outer Diameter11.5Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
855-884-3873info@si-bone.com

Regulatory Flags

DUNS number
830127168
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00869397000013XL Instrument Set4000622026-03-24
00869397000020Radiolucent Instrument Set4000912026-03-24
00869397000037Standard Instrument Set4000992026-03-24
00869397000044Removal System Instrument Set4001322026-03-24
008693970000517.5mm & 10.75mm Instrument Set4001452026-03-24
00810055525768iFuse INTRA Ti Implant6030K2026-02-17
00810055524754iGPS 4.3mm Drill Bit5030422025-09-23
00810055524761iGPS 7.0mm Drill Bit502137-07002025-09-23
00810055524778iGPS 8.5mm Drill Bit502137-08502025-09-23
00810055524785iGPS 10.5mm Drill Bit502137-10502025-09-23
00810055524792Granite iGPS 8.5mm Awl Tip Tap502139-08502025-09-23
00810055524808Granite iGPS 9.0mm Awl Tip Tap502139-09002025-09-23
00810055524815Granite iGPS 9.5mm Awl Tip Tap502139-09502025-09-23
00810055524822Granite iGPS 10.0mm Awl Tip Tap502139-10002025-09-23
00810055524839Granite iGPS 10.5mm Awl Tip Tap502139-10502025-09-23
00810055524846TORQ iGPS 6.0mm Awl Tip Tap503124-06002025-09-23
00810055524853TORQ iGPS 8.5mm Awl Tip Tap503124-08502025-09-23
00810055524860TORQ iGPS 9.25mm Awl Tip Tap502142-09252025-09-23
00810055524877iGPS Blunt Dissector4005222025-09-23
00810055524884TORQ iGPS Driver4030172025-09-23

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Primary DIBrandCompanyProduct codePublished
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00810131882730Joint Fusion Office KitSURGENTEC, LLCOUR2026-03-09
00810131882204TiLink-P Instrument Removal Tool - MetalSURGENTEC, LLCOUR2026-02-25
00810055525768iFuse INTRA Ti ImplantSi-Bone Inc.OUR2026-02-17
00889929072189NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCOUR2026-02-10
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