FDA.reportPublic FDA data

intellijoint HIP®

Primary DI
00628184003763
Brand
intellijoint HIP®
Company
Intellijoint Surgical Inc
Model
000-0376
Device description
Femoral Disc, Round, Sterile
Published
2019-02-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172849000
K191507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172849000Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument TrayIntellijoint Surgical, Inc.2017-11-16OLO
K191507000Intellijoint® Navigation SystemIntellijoint Surgical, Inc.2019-10-01OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10628184003760PackageGS110In Commercial Distribution
00628184003763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062818400376010628184003760
00628184003763006281840037636281840037630628184003763

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-519-342-3178info@intellijointsurgical.com

Regulatory Flags#

DUNS number
202958070
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628184004500Intellijoint VIEW000-04502026-06-09
00628184005705Intellijoint KNEE®000-05702026-03-18
00628184005743Intellijoint KNEE(R)000-05742026-02-25
00628184007907Intellijoint Navigation System000-07902025-11-04
00628184007914Intellijoint Navigation System000-07912025-11-04
00628184007976Intellijoint Navigation System000-07972025-11-04
00628184007983Intellijoint Navigation System000-07982025-11-04
00628184009604Intellijoint Navigation System000-09602025-11-04
00628184009611Intellijoint Navigation System000-09612025-11-04
00628184009628Intellijoint Navigation System000-09622025-11-04
00628184008003intellijoint HIP (R)000-08002024-06-28
00628184008010intellijoint HIP (R)000-08012024-06-28
00628184008027intellijoint KNEE (R)000-08022024-06-28
00628184008034intellijoint HIP (R)000-08032024-06-28
00628184008119intellijoint HIP (R)000-08112024-06-28
00628184008126intellijoint HIP (R)000-08122024-06-28
00628184008133intellijoint HIP (R)000-08132024-06-28
00628184008140intellijoint HIP (R)000-08142024-06-28
00628184008157intellijoint KNEE (R)000-08152024-06-28
00628184003770intellijoint HIP®000-03772019-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556925171REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00885556925188REAL INTELLIGENCESmith & Nephew, Inc.OLO2026-07-30
00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
00885556919743Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919767Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
04056481146429Automatic RegsitrationBrainlab SEOLO2026-02-20
00810180350051ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
00810180350099ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
00810180350112ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-11-17
04056481146702Curve NavigationBrainlab SEOLO2025-10-13
04056481146054Patient Reference Rod-Clamp Spine & TraumaBrainlab SEOLO2025-09-19
006283415213837D Surgical Universal Array (5)7D Surgical ULCOLO2025-07-28
006283415213907D Surgical Universal Array (6)7D Surgical ULCOLO2025-07-28
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE SBrainlab SEOLO2025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE LBrainlab SEOLO2025-06-17
04056481146320Alignment Software SpineBrainlab SEOLO2025-06-16
00850042604311Paradigm Drill Guide TrocarProprio, Inc.OLO2025-06-09
00810180350266ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350433ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350525ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350556ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350563ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00810180350693ARVIS ®KICO KNEE INNOVATION COMPANY PTY LIMITEDOLO2025-05-23
00850030914347SkyWalkerMicroport Navibot International LLCOLO2025-04-24
00850030914354SkyWalkerMicroport Navibot International LLCOLO2025-04-24
05056139245374Apollo KneeCORIN LTDOLO2025-04-07
05056139250644Apollo KneeCORIN LTDOLO2025-04-07
00850042604014ParadigmProprio, Inc.OLO2025-03-21
00850042604168ParadigmProprio, Inc.OLO2025-03-21
00850042604175ParadigmProprio, Inc.OLO2025-03-21