FDA.reportPublic FDA data

iFuse Granite Implant System

Primary DI
00810055520961
Brand
iFuse Granite Implant System
Company
Si-Bone Inc.
Model
400302-1150
Device description
Bedrock Granite 11.5mm Cannulated Tap
Published
2022-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220195000iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.2022-05-26OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055520961PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055520961008100555209618100555209610810055520961

GMDN Terms#

Term, Definition table
TermDefinition
Sacroiliac joint transarticular fixation/arthrodesis implantation kitA collection of non-sterile surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
830127168
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055525225Onyx 4.5 mm Navigated Cannulated Tap400539-04502026-09-30
00810055525232Onyx 5.5mm Navigated Cannulated Tap400539-05502026-09-30
00810055525249Onyx 6.5mm Navigated Cannulated Tap400539-06502026-09-30
00810055525256Onyx 7.5mm Navigated Cannulated Tap400539-07502026-09-30
00810055525263Onyx 4.5 mm Navigated Awl Tip Tap400540-04502026-09-30
00810055525270Onyx 5.5 mm Navigated Awl Tip Tap400540-05502026-09-30
00810055525287Onyx 6.5 mm Navigated Awl Tip Tap400540-06502026-09-30
00810055525294Onyx 7.5 mm Navigated Awl Tip Tap400540-07502026-09-30
00810055525720Onyx Navigated Locking Driver403035-01002026-09-30
00810055525966Onyx Navigated Locking Driver, Cannulated403035-02002026-09-30
00810055526284Onyx iGPS Awl Tip Tap 4.5mm503189-04502026-09-30
00810055526291Onyx iGPS Awl Tip Tap 5.5mm503189-05502026-09-30
00810055526307Onyx iGPS Awl Tip Tap 6.5mm503189-06502026-09-30
00810055526314Onyx iGPS Awl Tip Tap 7.5mm503189-07502026-09-30
00810055526321Onyx iGPS Driver4030572026-09-30
008100555263905.5 mm x 25 mm iFuse Granite Onyx Implant055025BG2026-09-30
008100555264065.5 mm x 30 mm iFuse Granite Onyx Implant055030BG2026-09-30
008100555264135.5 mm x 35 mm iFuse Granite Onyx Implant055035BG2026-09-30
008100555264205.5 mm x 40 mm iFuse Granite Onyx Implant055040BG2026-09-30
008100555264375.5 mm x 45 mm iFuse Granite Onyx Implant055045BG2026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867620612Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620629Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620636Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620643Arthrex®ARTHREX, INC.LXH2026-10-01
M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
00840606191425PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedELEVATION SPINE, INC.LXH2026-09-29
00810055525300Onyx 4.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525317Onyx 5.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525324Onyx 6.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525331Onyx 7.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525348Onyx 4.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525355Onyx 5.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525362Onyx 6.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525379Onyx 7.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525386Onyx Feeler ProbeSi-Bone Inc.LXH2026-09-29
00810055525393Onyx Straight ProbeSi-Bone Inc.LXH2026-09-29
00810055525409Onyx Curved ProbeSi-Bone Inc.LXH2026-09-29
00810055525416Onyx 8.25mm TrephineSi-Bone Inc.LXH2026-09-29
00810055525423Onyx Threaded Removal DriverSi-Bone Inc.LXH2026-09-29
00810055525430Onyx 5.5 & 6.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525447Onyx 7.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525454Onyx Counter Torque, ShortSi-Bone Inc.LXH2026-09-29
00810055525461Onyx Counter TorqueSi-Bone Inc.LXH2026-09-29
00810055525478Onyx Counter Torque, LongSi-Bone Inc.LXH2026-09-29
00810055525485Onyx Head TurnerSi-Bone Inc.LXH2026-09-29