FDA.reportPublic FDA data

U2™ Hip

Primary DI
04719872167006
Brand
U2™ Hip
Company
UNITED ORTHOPEDIC CORP.
Model
9104-6040-RC
Catalog number
9104-6040-RC
Device description
U2 Broach, #4
Published
2017-05-15
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
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111546000
K121777000
K122185000
K132207000
K132455000
K151316000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111546000U2 HIP SYSTEMUnited Orthopedic Corp.2011-07-01LPH
K121777000U2 ACETABULAR CUP, PLASMA SPRAYUnited Orthopedic Corp.2012-07-18LPH
K122185000U-MOTION II ACETABULAR SYSTEMUnited Orthopedic Corp.2013-02-22LZO
K132207000UTF STEM-REDUCED, ADDITIONAL SIZESUnited Orthopedic Corporation2013-08-30LPH
K132455000U-MOTION II PS+ CUPUnited Orthopedic Corp.2013-09-03LZO
K151316000U2 Hip Stem, Ti Porous Coated, MatrixUnited Orthopedic Corporation2015-08-13LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872167006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872167006047198721670064719872167006

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.

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

Regulatory Flags#

DUNS number
656700556
Device count
1
DM 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
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
07613327380392TRIDENT IIHowmedica Osteonics Corp.LZO2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.MEH2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.JDI2018-02-12
07613327380392TRIDENT IIHowmedica Osteonics Corp.LPH2018-02-12
07613327345001Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345001Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345018Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345025Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345032Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345049Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345063Trident IIHowmedica Osteonics Corp.LPH2016-10-20
07613327345063Trident IIHowmedica Osteonics Corp.LZO2016-10-20
07613327345063Trident IIHowmedica Osteonics Corp.MEH2016-10-20
07613327345063Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345070Trident IIHowmedica Osteonics Corp.JDI2016-10-20
07613327345070Trident IIHowmedica Osteonics Corp.LZO2016-10-20