FDA.reportPublic FDA data

U2 Total Knee System

Primary DI
04719886907179
Brand
U2 Total Knee System
Company
UNITED ORTHOPEDIC CORP.
Model
9423-6210
Catalog number
9423-6210
Device description
PSA Tibial punch, #1~#2
Published
2025-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04719886907179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719886907179047198869071794719886907179

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
04719886907186U2 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
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
00887868493188Vanguard® Microplasty® InstrumentsBiomet Orthopedics, LLCHWP2022-03-19