FDA.reportPublic FDA data

U2 Total Knee System

Primary DI
04719886907186
Brand
U2 Total Knee System
Company
UNITED ORTHOPEDIC CORP.
Model
9423-6220
Catalog number
9423-6220
Device description
PSA Tibial punch, #3~#4
Published
2025-04-25
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
HWPPunch, Femoral Neck

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWPPunch, Femoral NeckOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719886907186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719886907186047198869071864719886907186

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
656700556
Device count
1
Premarket exempt
true
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
04719886912524Locking Cage9208-8110-RA9208-8110-RA2026-03-03
04719886912951Locking Cage1308-2150-RA1308-2150-RA2026-03-03
04719886912968Locking Cage1308-2154-RA1308-2154-RA2026-03-03
04719886912975Locking Cage1308-2158-RA1308-2158-RA2026-03-03
04719886912982Locking Cage1308-2162-RA1308-2162-RA2026-03-03
04719886912999Locking Cage1308-2166-RA1308-2166-RA2026-03-03
04719886913002Locking Cage1308-2170-RA1308-2170-RA2026-03-03
04719886913019Locking Cage1308-2250-RA1308-2250-RA2026-03-03
04719886913026Locking Cage1308-2254-RA1308-2254-RA2026-03-03
04719886913033Locking Cage1308-2258-RA1308-2258-RA2026-03-03
04719886913040Locking Cage1308-2262-RA1308-2262-RA2026-03-03
04719886913057Locking Cage1308-2266-RA1308-2266-RA2026-03-03
04719886913064Locking Cage1308-2270-RA1308-2270-RA2026-03-03
04719886913071U-Motion II9206-8110-RA9206-8110-RA2026-03-03
04719886912005U2 Total Knee System2603-6313-RC2603-6313-RC2026-03-02
04719886912012U2 Total Knee System2603-6323-RC2603-6323-RC2026-03-02
04719886912029U2 Total Knee System2603-6333-RC2603-6333-RC2026-03-02
04719886912036U2 Total Knee System2603-6343-RC2603-6343-RC2026-03-02
04719886912043U2 Total Knee System2603-6353-RC2603-6353-RC2026-03-02
04719886912050U2 Total Knee System2603-6363-RC2603-6363-RC2026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886907179U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWP2025-04-25
04719886907193U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWP2025-04-25
04719886905526U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWP2025-03-05
00190776379155MillenniumAvalign Technologies, Inc.HWP2023-10-16
04026575290017Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575290031Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575290055Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575290062Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575292080Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575292097Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575292103Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575292127Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575407576Endo-Model Knee System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2023-01-04
04026575312832LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312856LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312870LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312894LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312917LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312931LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312955LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312979LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575312993LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575313013LinkSymphoKnee - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-16
04026575301935Link Embrace Shoulder System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-15
04026575217762SPARK - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-15
04026575301959Link Embrace Shoulder System - InstrumentsWALDEMAR LINK GmbH & Co. KGHWP2022-12-15
04719886890440U2 Total Knee SystemUNITED ORTHOPEDIC CORP.HWP2022-10-14
00840277124241Innomed, Inc.INNOMED, INC.HWP2022-08-08
00887868494406Vanguard® Microplasty®Biomet Orthopedics, LLCHWP2022-06-22
00887868497377Vanguard®Biomet Orthopedics, LLCHWP2022-04-23