iUni® iPoly™ Insert Kit

Primary DI
M572RUK0101000011
Brand
iUni® iPoly™ Insert Kit
Company
Conformis, Inc.
Model
RUK010100001
Catalog number
RUK0101000
Device description
N/A
Published
2015-10-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOGKnee Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOGKnee Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072586000CONFORMIS UNI-CONDYLAR KNEE SYSTEMConformis, Inc.2007-11-08HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M572RUK0101000011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Unicondylar knee insertA sterile implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision unicompartmental knee joint replacement. It is a one-piece contoured device typically made of polyethylene (PE).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-345-9001customer-service@conformis.com

Regulatory Flags#

DUNS number
808821883
Device count
1
Kit
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

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00810933031206Cordera Hip System Radel Liner Impactors 36mm1080-6571080-6572022-03-07
00810933031213Cordera Hip System Radel Liner Impactors 40mm1080-6581080-6582022-03-07
00810933031220Cordera Hip System T-handle Quick Connect1080-6591080-6592022-03-07
00810933031237Cordera Hip System OrthoGroup Cup Impactor1080-6601080-6602022-03-07
00850268007187iTotal® Impactor Head1080-5412016-10-24
00850268007194iTotal® Impactor Head1080-5352016-10-24
00850268007200iTotal® CR Tibial Tray Impactor Tip1080-5362016-10-24
00850268007217iTotal® PS Tibial Tray Impactor Tip1080-5422016-10-24
00850268007224iTotal® Poly Impactor Tip1080-5242016-10-24
M572HDL060C24S011iTotal® Hip Replacement SystemHDL060C24S01HDL060C24S2018-08-06
M572HDL060D24S011iTotal® Hip Replacement SystemHDL060D24S01HDL060D24S2018-07-30
M572HDL060D34S011iTotal® Hip Replacement SystemHDL060D34S01HDL060D34S2018-08-06
M572HDL060E24S011iTotal® Hip Replacement SystemHDL060E24S01HDL060E24S2018-08-06
M572HDL060E34S011iTotal® Hip Replacement SystemHDL060E34S01HDL060E34S2018-08-06
M572HDL060F24S011iTotal® Hip Replacement SystemHDL060F24S01HDL060F24S2018-08-06
M572HDL060F34S011iTotal® Hip Replacement SystemHDL060F34S01HDL060F34S2018-08-06
M572HDL060C10S011iTotal® Hip Replacement SystemHDL060C10S01HDL060C10S2018-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVOOG2026-05-28
07630030891595My Knee Femoral Cutting BlocksMedacta International SAOOG2023-09-13
07630030868047My KneeMedacta International SAOOG2021-07-05
07630030868023My Knee Femoral Cutting BlocksMedacta International SAOOG2021-06-25
08800068942272EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
08800068942289EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
08800068942296EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
08800068942302EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
08800068942319EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
08800068942326EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
08800068942333EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
08800068942340EXULT Knee Replacement SystemCorentec Co., LtdOOG2020-08-17
07630030847868My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847875My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847905My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847912My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847943My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847950My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847981My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030847998My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848025My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848032My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848063My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848070My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848100My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848117My Knee Femoral Cutting BlocksMedacta International SAOOG2014-11-18
07630030848131My Knee Tibial Cutting BlocksMedacta International SAOOG2014-11-18
07630030848162My Knee Tibial Cutting BlocksMedacta International SAOOG2014-11-18
07630030848179My Knee Tibial Cutting BlocksMedacta International SAOOG2014-11-18
07630030848209My Knee Tibial Cutting BlocksMedacta International SAOOG2014-11-18