FDA.reportPublic FDA data

iFuse Granite-Closed Head Implant System

Primary DI
00810055522347
Brand
iFuse Granite-Closed Head Implant System
Company
Si-Bone Inc.
Model
135060CH
Device description
13.5mm x 60mm iFuse-Granite Closed Head Implant
Published
2023-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OURSacroiliac Joint FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055522347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055522347008100555223478100555223470810055522347

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Length60Millimeter
Outer Diameter13.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-884-3873info@si-bone.com

Regulatory Flags#

DUNS number
830127168
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
00810055525935Granite Point Lock Set Screw5031752025-08-25
00810055525867Driver Sleeve 2 Wrench Assembly4030432025-10-31
00810055525614BL Registration Tube - Broach5030942025-10-20
00810055525621BL Registration Tube - Impactor5030952025-10-20
00810055525638BL Adapter - Dovetail Mount4030022025-10-20
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07290115935578PER Trial 60PREMIA SPINE LTDNKB2026-07-22
07290115935691PER Trial 50PREMIA SPINE LTDNKB2026-07-22
00840466901035PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
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00840466901172PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.NKB2026-07-21