FDA.reportPublic FDA data

U2 Total Knee System

Primary DI
04719872177968
Brand
U2 Total Knee System
Company
UNITED ORTHOPEDIC CORP.
Model
9303-8029
Catalog number
9303-8029
Device description
Tibial insert trial case
Published
2018-06-25
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
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140075000U2 FEMORAL COMPONENT, CR, POROUS COATEDUnited Orthopedic Corp.2014-06-13MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872177968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872177968047198721779684719872177968

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA flat shallow vessel, usually with a raised rim, providing a suitable platform for containing many medical, usually surgical instruments and items. It is typically made of stainless steel and designed to fit into other devices, e.g., supply trolleys, storage systems and sterilizers; it is not dedicated to sterilization. This device may or may not be fitted with a lid or cover. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+886229294567service@uoc.com.tw

Regulatory Flags#

DUNS number
656700556
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
04719886896602United Hip System1309-10011309-10012026-10-15
04719886899030United Hip System1409-76441409-76442026-10-15
04719886899047United Hip System1409-76461409-76462026-10-15
04719886899054United Hip System1409-76481409-76482026-10-15
04719886899061United Hip System1409-76501409-76502026-10-15
04719886899078United Hip System1409-76521409-76522026-10-15
04719886899085United Hip System1409-76541409-76542026-10-15
04719886899092United Hip System1409-76561409-76562026-10-15
04719886899108United Hip System1409-76581409-76582026-10-15
04719886899115United Hip System1409-76621409-76622026-10-15
04719886899122United Hip System1409-76661409-76662026-10-15
04719886899139United Hip System1409-77481409-77482026-10-15
04719886899146United Hip System1409-77501409-77502026-10-15
04719886899153United Hip System1409-77521409-77522026-10-15
04719886899160United Hip System1409-77541409-77542026-10-15
04719886899177United Hip System1409-77561409-77562026-10-15
04719886899184United Hip System1409-77581409-77582026-10-15
04719886899191United Hip System1409-77621409-77622026-10-15
04719886899207United Hip System1409-77661409-77662026-10-15
04719886899214United Hip System1409-78541409-78542026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001F9F00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001FF640PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001FLI00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001KF5I0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001L0LD0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001L4120PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001L7FI0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0001L9260PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000200F30PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000201K20PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000202L80PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000203ID0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000205I00PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0002066I0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000207330PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000208K50PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL0002098I0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL000209F30PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020D0F0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020F080PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020F670PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020I510PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20
TKRL00020IBI0PointCloud Knee InstrumentsUnik Orthopedics Inc.MBH2026-10-20