FDA.report

iFuse Granite-Closed Head Implant System

Primary DI
00810055522620
Brand
iFuse Granite-Closed Head Implant System
Company
Si-Bone Inc.
Model
105120CH
Device description
10.5mm x 120mm 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
00810055522620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055522620008100555226208100555226200810055522620

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes

TypeValueUnit
Length120Millimeter
Outer Diameter10.5Millimeter

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

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00869397000044Removal System Instrument Set4001322026-03-24
008693970000517.5mm & 10.75mm Instrument Set4001452026-03-24
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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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