FDA.reportPublic FDA data

Femoral Epidummy

Primary DI
EPIS34129PF0
Brand
Femoral Epidummy
Company
Episurf Operations AB
Model
D29
Catalog number
34129PF
Published
2023-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221048000Episealer Patellofemoral SystemEpisurf Medical, Inc.2022-12-23KRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EPIS34129PF0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, single-useA collection of surgical instruments intended to be used for cutting and forming bone to enable the implantation of a joint prosthesis. The instruments include various metallic and/or plastic disposable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks, trial prosthesis) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
352393402
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EPIS960010EpisurfView1.02026-03-17
EPIS18100PF0Episealer Knee Revision GuideFirst version18100PF2023-07-24
EPIS31120PF0Femoral ComponentD2031120PF2023-07-24
EPIS31125PF0Femoral ComponentD2531125PF2023-07-24
EPIS31129PF0Femoral ComponentD2931129PF2023-07-24
EPIS32120PF0Femoral EpidrillD2032120PF2023-07-24
EPIS32125PF0Femoral EpidrillD2532125PF2023-07-24
EPIS32129PF0Femoral EpidrillD2932129PF2023-07-24
EPIS33120PF0Femoral Drilling SocketD2033120PF2023-07-24
EPIS33125PF0Femoral Drilling SocketD2533125PF2023-07-24
EPIS33129PF0Femoral Drilling SocketD2933129PF2023-07-24
EPIS33420PF0Femoral Adjustment SocketD2033420PF2023-07-24
EPIS33425PF0Femoral Adjustment SocketD2533425PF2023-07-24
EPIS33429PF0Femoral Adjustment SocketD2933429PF2023-07-24
EPIS33720PF0Femoral EpiguideD2033720PF2023-07-24
EPIS33725PF0Femoral EpiguideD2533725PF2023-07-24
EPIS33729PF0Femoral EpiguideD2933729PF2023-07-24
EPIS34120PF0Femoral EpidummyD2034120PF2023-07-24
EPIS34125PF0Femoral EpidummyD2534125PF2023-07-24
EPIS37320PF0Femoral EpimandrelD2037320PF2023-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327127423INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127447INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
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07613327127478INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127522INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327049305AvonHowmedica Osteonics Corp.KRR2017-06-19
07613154557431INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051186INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051209INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327127546INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327127553INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24