FDA.reportPublic FDA data

intellijoint HIP®

Primary DI
00628184003008
Brand
intellijoint HIP®
Company
Intellijoint Surgical Inc
Model
000-0300
Device description
System, Intellijoint HIP, Portable, Demo
Published
2017-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
K162364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162364000Intellijoint HIP Generation 2A SystemIntellijoint Surgical, Inc.2017-03-02OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628184003008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628184003008006281840030086281840030080628184003008

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
Serial number
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
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00887868573057Sesamoid® SystemOrthosoft IncOLO2026-10-26
00887868579608ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579615ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579622ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579639ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579646ROSA® RoboticsOrthosoft IncOLO2026-10-26
00889024705999NavitrackerOrthosoft IncOLO2026-10-26
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-23
04056481146207Spine PlanningBrainlab SEOLO2026-10-23
00840466901011PrimusSPINAL ELEMENTS, INC.OLO2026-10-22
00840606184656OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187503OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187527OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187541OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
04056481147112RT ElementsBrainlab SEOLO2026-10-22
00190376632919InvictusALPHATEC SPINE, INC.OLO2026-10-20
00889024699762ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncOLO2026-06-26
00887868581083ROSA® RoboticsOrthosoft IncOLO2026-02-20
00889024703186ROSA® ShoulderOrthosoft IncOLO2026-01-27