FDA.reportPublic FDA data

iDuo® Patella

Primary DI
M572PAB0113508021
Brand
iDuo® Patella
Company
Conformis, Inc.
Model
PAB011350802
Catalog number
PAB0113508
Published
2019-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093513000IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMConformis, Inc.2009-12-16NPJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M572PAB0113508021PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
808821883
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810933031114Cordera Hip System Offset Cup Impactor, Enztec1080-6461080-6462022-03-07
00810933031183Cordera Hip System Radel Liner Impactors 28mm1080-6551080-6552022-03-07
00810933031190Cordera Hip System Radel Liner Impactors 32mm1080-6561080-6562022-03-07
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
07613327127423INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
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07613327127485INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127522INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.NPJ2017-11-24
07613327049305AvonHowmedica Osteonics Corp.NPJ2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051209INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327127546INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327127553INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24
07613327127577INSTRUMENTHowmedica Osteonics Corp.NPJ2016-09-24