FDA.reportPublic FDA data

iFuse Navigation Tracking System

Primary DI
00855369008934
Brand
iFuse Navigation Tracking System
Company
Si-Bone Inc.
Model
400402
Device description
Universal Pin Guide
Published
2024-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232800000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232800000Navigation Tracking InstrumentsSI-BONE, Inc.2024-02-23OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855369008934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855369008934008553690089348553690089340855369008934

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
00810055525751Onyx Dual End Set Screw Starter5031022026-10-06
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

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