FDA.reportPublic FDA data

Obturator

Primary DI
00810055522811
Brand
Obturator
Company
Si-Bone Inc.
Model
501821
Device description
Obturator
Published
2024-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055522811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055522811008100555228118100555228110810055522811

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide obturatorA surgical device designed to fill the lumen of a drill guide during its insertion to a surgical site primarily to prevent tissue obstruction of the drill guide lumen. When the drill guide is firmly placed at the chosen position on the bone surface, the obturator is removed. It is typically a rod with a rounded distal end, which protrudes out of the drill guide, and a knob-like handle that functions as a regulator to control the length of the protruding end and to remove it from the drill guide. It is typically made of a high-grade stainless steel. 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
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151066mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151088mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23