FDA.reportPublic FDA data

U2 Bipolar Implant

Primary DI
04719872178798
Brand
U2 Bipolar Implant
Company
UNITED ORTHOPEDIC CORP.
Model
1503-4250
Catalog number
1503-4250
Device description
U2 Bipolar trial, φ50mm, ID 32mm
Published
2022-11-01
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
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101670000
K110245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101670000UNITED U2 BIPOLAR IMPLANTUnited Orthopedic Corp.2010-10-08KWY
K110245000UNITED UTF STEMUnited Orthopedic Corporation2011-08-04LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872178798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872178798047198721787984719872178798

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

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
04719886896466United Hip System1209-12421209-12422026-09-24
04719886896473United Hip System1209-12441209-12442026-09-24
04719886896480United Hip System1209-12481209-12482026-09-24
04719886896497United Hip System1209-12521209-12522026-09-24
04719886896503United Hip System1209-12541209-12542026-09-24
04719886896510United Hip System1209-12581209-12582026-09-24
04719886896527United Hip System1209-12621209-12622026-09-24
04719886896534United Hip System1209-12661209-12662026-09-24
04719886896541United Hip System1209-18481209-18482026-09-24
04719886896558United Hip System1209-18521209-18522026-09-24
04719886896565United Hip System1209-18541209-18542026-09-24
04719886896572United Hip System1209-18581209-18582026-09-24
04719886896589United Hip System1209-18621209-18622026-09-24
04719886896596United Hip System1209-18661209-18662026-09-24
04719886896633United Hip System1309-10461309-10462026-09-24
04719886896640United Hip System1309-10481309-10482026-09-24
04719886896657United Hip System1309-10501309-10502026-09-24
04719886896664United Hip System1309-10521309-10522026-09-24
04719886896671United Hip System1309-10541309-10542026-09-24
04719886896688United Hip System1309-10561309-10562026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896640United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896657United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896664United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896671United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896688United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896695United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896701United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896718United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896725United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896732United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896749United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896756United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896763United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896770United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896787United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24