FDA.reportPublic FDA data

KneePlus

Primary DI
03760297030322
Brand
KneePlus
Company
PIXEE MEDICAL
Model
Knee+
Catalog number
KNS160
Device description
Software for Total Knee Arthroplasty
Published
2024-12-10
Public version status
New
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760297030322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760297030322037602970303223760297030322

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.

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

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
03760297030179Right Proximal Cutting GuideKnee+KNI0142022-10-04
03760297030186Left Proximal Cutting GuideKnee+KNI0152022-10-04
03760297030070Knee StylusKnee+KNI0092021-10-08
03760297030087Control ToolKnee+KNI0102021-10-08
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
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
07640221373021PERLA NAVSpineArt SAOLO2026-05-07
07640221373052PERLA NAVSpineArt SAOLO2026-05-07
07640221373069PERLA NAVSpineArt SAOLO2026-05-07
07640221373113PERLA NAVSpineArt SAOLO2026-05-07
07640221373120PERLA NAVSpineArt SAOLO2026-05-07
07640221373137PERLA NAVSpineArt SAOLO2026-05-07
07640221373144PERLA NAVSpineArt SAOLO2026-05-07
07640221373151PERLA NAVSpineArt SAOLO2026-05-07
07640221373168PERLA NAVSpineArt SAOLO2026-05-07
07640221373175PERLA NAVSpineArt SAOLO2026-05-07
07640221373182PERLA NAVSpineArt SAOLO2026-05-07
07640221373199PERLA NAVSpineArt SAOLO2026-05-07
07640221373205PERLA NAVSpineArt SAOLO2026-05-07
07640221373212PERLA NAVSpineArt SAOLO2026-05-07
07640221373229PERLA NAVSpineArt SAOLO2026-05-07
07640221373236PERLA NAVSpineArt SAOLO2026-05-07
07640221373243PERLA NAVSpineArt SAOLO2026-05-07
07640221373250PERLA NAVSpineArt SAOLO2026-05-07
07640221373267PERLA NAVSpineArt SAOLO2026-05-07
07640221373274PERLA NAVSpineArt SAOLO2026-05-07
07640221373281PERLA NAVSpineArt SAOLO2026-05-07