FDA.reportPublic FDA data

Right Proximal Cutting Guide

Primary DI
03760297030179
Brand
Right Proximal Cutting Guide
Company
PIXEE MEDICAL
Model
Knee+
Catalog number
KNI014
Device description
Reusable instrument for Total Knee Arthroplasty
Published
2022-10-04
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
OLOOrthopedic Stereotaxic Instrument
SBFOrthopedic Augmented Reality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2
SBFOrthopedic Augmented RealityNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760297030179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760297030179037602970301793760297030179

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33458101365contact@pixee-medical.com

Regulatory Flags#

DUNS number
270195749
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760297030490KneePlusKnee+KCS1702026-05-27
03760297030223SHA Outer ringSHAPEA0062023-06-16
03760297030247SHA ConnectorSHAPEA0072023-06-16
03760297030209FX Shoulder Positioning SystemFXSPS0012022-10-14
03760297030117KneePlusKnee+KNS0022021-10-08
03760297030438Orientation and resection mechanismKnee+MEC00062025-04-18
03760297030445Adjustable cutting guide adaptorKnee+CGA00062025-04-18
03760297030452KneeTools Instrument Box V6Knee+KTB00062025-04-18
03760297030469KneePlusKnee+KNS1702025-04-18
03760297030483Kit KneeTools V6Knee+2025-04-18
03760297030285Modular PointerKnee+KNI0162024-12-10
03760297030155Slim Bone ReferenceKnee+KNI0122022-10-04
03760297030162Slim Universal Cutting GuideKnee+KNI0132022-10-04
03760297030186Left Proximal Cutting GuideKnee+KNI0152022-10-04
03760297030070Knee StylusKnee+KNI0092021-10-08
03760297030087Control ToolKnee+KNI0102021-10-08
03760297030322KneePlusKnee+KNS1602024-12-10
03760297030339KneeTools V5 KitKnee+KNK0052024-12-10
03760297030315KneePlusKnee+KNS0022023-06-16
03760297030025Ankle ClampKnee+KNI0042021-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760297030490KneePlusPIXEE MEDICALSBF2026-05-27
10885862656117NewtonExactech, Inc.OLO2026-05-27
10885862656124NewtonExactech, Inc.OLO2026-05-27
10885862656131NewtonExactech, Inc.OLO2026-05-27
10885862656148NewtonExactech, Inc.OLO2026-05-27
10885862656155NewtonExactech, Inc.OLO2026-05-27
10885862656162NewtonExactech, Inc.OLO2026-05-27
10885862656179NewtonExactech, Inc.OLO2026-05-27
07613327594829Common Shoulder DriverMAKO SURGICAL CORP.OLO2026-05-21
07613327595543MakoMAKO SURGICAL CORP.OLO2026-05-21
07630345729316NextAR TSA PlatformMedacta International SASBF2026-04-13
07630345728975Navigation System for Knee surgeryMedacta International SAOLO2026-01-26
07630345725912NextAR Spine PlatformMedacta International SASBF2026-01-20
07630030846656Navigation System for Knee surgeryMedacta International SAOLO2026-01-19
07630030846663Navigation System for Knee surgeryMedacta International SAOLO2026-01-19
07613327620306N/AStryker Leibinger GmbH & Co. KGOLO2025-10-28
07613327579864N/AStryker Leibinger GmbH & Co. KGOLO2025-10-13
07613327627558RPSSTRYKER CORPORATIONOLO2025-10-10
07613327645002RPSSTRYKER CORPORATIONOLO2025-10-07
07613327631814RPSStryker Leibinger GmbH & Co. KGOLO2025-10-03
07613327631753RPSSTRYKER CORPORATIONOLO2025-10-01
07613327631760RPSSTRYKER CORPORATIONOLO2025-10-01
07613252196259FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
07613327592979CORESTRYKER CORPORATIONOLO2024-08-23
07630542702204NextAR RSA Platform Medacta International SASBF2023-11-21
07630542702211NextAR RSA Platform Medacta International SASBF2023-11-21
07630345779939NextAR Spine Platform Medacta International SASBF2023-07-24
07630345797063NextAR Spine Platform Medacta International SASBF2023-07-24
07630345797070NextAR Spine Platform Medacta International SASBF2023-07-24
07630345797087NextAR Spine Platform Medacta International SASBF2023-07-24