FDA.reportPublic FDA data

intellijoint HIP (R)

Primary DI
00628184008010
Brand
intellijoint HIP (R)
Company
Intellijoint Surgical Inc
Model
000-0801
Device description
Intellijoint HIP Kit Ellipse Disc
Published
2024-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
K191507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191507000Intellijoint® Navigation SystemIntellijoint Surgical, Inc.2019-10-01OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628184008010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628184008010006281840080106281840080100628184008010

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
1-519-342-3178regulatory@intellijointsurgical.com

Regulatory Flags#

DUNS number
202958070
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
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
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
00628184002827intellijoint HIP®000-02822017-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327460667Navigation EnabledStryker CorporationOLO2019-10-16
07613327460674Navigation EnabledStryker CorporationOLO2019-10-16
07613327460681Navigation EnabledStryker CorporationOLO2019-10-16
07613327460698Navigation EnabledStryker CorporationOLO2019-10-16
07613327460704Navigation EnabledStryker CorporationOLO2019-10-16
07613327460711Navigation EnabledStryker CorporationOLO2019-10-16
07613327460728Navigation EnabledStryker CorporationOLO2019-10-16
07613327460735Navigation EnabledStryker CorporationOLO2019-10-16
07613327460742Navigation EnabledStryker CorporationOLO2019-10-16
07613327460759Navigation EnabledStryker CorporationOLO2019-10-16
07613327460766Navigation EnabledStryker CorporationOLO2019-10-16
07613327460773Navigation EnabledStryker CorporationOLO2019-10-16
07613327460780Navigation EnabledStryker CorporationOLO2019-10-16
07613327460797Navigation EnabledStryker CorporationOLO2019-10-16
07613327460810Navigation EnabledStryker CorporationOLO2019-10-16
07613327460827Navigation EnabledStryker CorporationOLO2019-10-16
07613327460834Navigation EnabledStryker CorporationOLO2019-10-16
07613327460841Navigation EnabledStryker CorporationOLO2019-10-16
07613327460858Navigation EnabledStryker CorporationOLO2019-10-16
07613327460865Navigation EnabledStryker CorporationOLO2019-10-16
07613327460872Navigation EnabledStryker CorporationOLO2019-10-16
07613327460889Navigation EnabledStryker CorporationOLO2019-10-16
07613327460896Navigation EnabledStryker CorporationOLO2019-10-16
07613327460902Navigation EnabledStryker CorporationOLO2019-10-16
07613327460919Navigation EnabledStryker CorporationOLO2019-10-16
07613327460926Navigation EnabledStryker CorporationOLO2019-10-16
07613327460933Navigation EnabledStryker CorporationOLO2019-10-16
07613327460940Navigation EnabledStryker CorporationOLO2019-10-16
07613327460957Navigation EnabledStryker CorporationOLO2019-10-16
07613327460964Navigation EnabledStryker CorporationOLO2019-10-16