FDA.reportPublic FDA data

U2 Total Knee System

Primary DI
04719886906622
Brand
U2 Total Knee System
Company
UNITED ORTHOPEDIC CORP.
Model
9323-3610
Catalog number
9323-3610
Device description
Universal reamer, Ø10.5mm
Published
2025-04-29
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
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719886906622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719886906622047198869066224719886906622

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868582158Affixus®Zimmer, Inc.HTO2026-03-19
03662663136693Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
03662663136709Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
03662663136723Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
00888867531659Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531666Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531673Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531697Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531703Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531710Arthrex®ARTHREX, INC.HTO2026-03-16
00843575120205Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120212Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120229Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120236Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120243Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120250Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120267Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120274Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00841731134707Hintermann Series VILEX LLCHTO2026-01-16
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04026575288465MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
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04026575288519MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288533MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06