FDA.reportPublic FDA data

Orientation and resection mechanism

Primary DI
03760297030438
Brand
Orientation and resection mechanism
Company
PIXEE MEDICAL
Model
Knee+
Catalog number
MEC0006
Device description
Reusable instrument for Total Knee Arthroplasty
Published
2025-04-18
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
SBFOrthopedic Augmented Reality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBFOrthopedic Augmented RealityNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760297030438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760297030438037602970304383760297030438

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
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
03760297030025Ankle ClampKnee+KNI0042021-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760297030490KneePlusPIXEE MEDICALSBF2026-05-27
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