FDA.reportPublic FDA data

KneePlus

Primary DI
03760297030124
Brand
KneePlus
Company
PIXEE MEDICAL
Model
Knee+
Catalog number
KNS002
Device description
Software for Total Knee Arthroplasty
Published
2022-10-04
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
03760297030124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760297030124037602970301243760297030124

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
+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
03760297030322KneePlusKnee+KNS1602024-12-10
03760297030339KneeTools V5 KitKnee+KNK0052024-12-10
03760297030315KneePlusKnee+KNS0022023-06-16

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Primary DI, Brand, Company table
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00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
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