FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446364627
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
244-02-111
Device description
EMPOWR POROUS FEMUR WITH HA NANO, 11R
Published
2021-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446364627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446364627001904463646271904463646270190446364627

GMDN Terms#

Term, Definition table
TermDefinition
Coated knee femur prosthesisA sterile implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154074504
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446839187DJO SURGICAL804-06-4182024-06-27
00190446839194DJO SURGICAL804-06-4192024-06-27
00190446839200DJO SURGICAL804-06-3182024-06-27
00190446839217DJO SURGICAL804-06-3192024-06-27
00888912024884DJO SURGICAL520-00-0002017-08-07
00190446263906DJO SURGICAL354-10-0402018-07-16
00190446264156DJO SURGICAL354-10-0652018-07-16
00190446264163DJO SURGICAL354-12-0402018-07-16
00190446264170DJO SURGICAL354-12-0652018-07-16
00190446264187DJO SURGICAL354-14-0402018-07-16
00190446264194DJO SURGICAL354-14-0652018-07-16
00190446978213DJO SURGICALS-2019692026-05-01
00190446978268DJO SURGICALS-2019702026-05-01
00190446978275DJO SURGICALS-2019712026-05-01
00190446978282DJO SURGICALS-2019722026-05-01
00888912078634DJO SURGICAL425-97-0052017-08-07
00888912078641DJO SURGICAL425-97-0062017-08-07
00888912078658DJO SURGICAL425-97-0072017-08-07
00888912078665DJO SURGICAL425-97-0082017-08-07
00888912078672DJO SURGICAL425-97-0092017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327014846TriathlonHowmedica Osteonics Corp.MBH2017-06-19
07613327000061INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000078INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000085INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000139INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000177INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000184INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000191INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000207INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000221INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000269INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000276INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000290INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000320INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000344INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000382INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000429INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000504INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327000511INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327010138INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327010145INSTRUMENTHowmedica Osteonics Corp.MBH2016-09-24
07613327013498TriathlonHowmedica Osteonics Corp.MBH2015-09-24
07613327013504TriathlonHowmedica Osteonics Corp.MBH2015-09-24
07613327013535TriathlonHowmedica Osteonics Corp.MBH2015-09-24
07613327013566TriathlonHowmedica Osteonics Corp.MBH2015-09-24
07613327014471ScorpioHowmedica Osteonics Corp.MBH2015-09-24
07613327014495ScorpioHowmedica Osteonics Corp.MBH2015-09-24
07613327014525ScorpioHowmedica Osteonics Corp.MBH2015-09-24
07613327014532ScorpioHowmedica Osteonics Corp.MBH2015-09-24
07613327014617ScorpioHowmedica Osteonics Corp.MBH2015-09-24