FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446254409
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
540-63-115
Device description
DISC ULNA 3X115MM RT W/ E+ BRNG
Published
2019-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDCProsthesis, Elbow, Constrained, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013042000DISCOVERY ELBOWBiomet Orthopedics, Inc.2001-10-10JDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446254409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446254409001904462544091904462544090190446254409

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154074504
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00713864000047DJO SURGICALS-2019962026-11-04
00190446851417DJO SURGICAL800-99-1652024-06-25
00190446735144DJO SURGICAL800-05-0802022-08-17
00190446735151DJO SURGICAL800-05-1322022-08-17
00190446735168DJO SURGICAL800-05-1332022-08-17
00190446735175DJO SURGICAL800-05-1342022-08-17
00190446735182DJO SURGICAL800-05-1352022-08-17
00190446735199DJO SURGICAL800-05-1362022-08-17
00190446735205DJO SURGICAL800-05-1372022-08-17
00190446735212DJO SURGICAL800-05-1382022-08-17
00190446735229DJO SURGICAL800-05-1392022-08-17
00190446735236DJO SURGICAL800-05-1402022-08-17
00190446735243DJO SURGICAL800-05-1412022-08-17
00190446735304DJO SURGICAL800-05-1462022-08-17
00190446735311DJO SURGICAL800-05-1472022-08-17
00190446735328DJO SURGICAL800-05-1482022-08-17
00190446735335DJO SURGICAL800-05-1492022-08-17
00190446735342DJO SURGICAL800-05-1502022-08-17
00190446735359DJO SURGICAL800-05-1512022-08-17
00190446735366DJO SURGICAL800-05-1522022-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902194029ARROWTELEFLEX INCORPORATEDJDC2026-08-01
07613327668889Modular ElbowHowmedica Osteonics Corp.JDC2025-02-24
07613327668902Modular ElbowHowmedica Osteonics Corp.JDC2025-02-24
07613327668919Modular ElbowHowmedica Osteonics Corp.JDC2025-02-24
08033390195225TEMA Elbow System LIMACORPORATE SPAJDC2024-07-26
08033390150934TEMA ElbowLIMACORPORATE SPAJDC2023-03-10
08033390150941TEMA ElbowLIMACORPORATE SPAJDC2023-03-10
08033390173186TEMA ElbowLIMACORPORATE SPAJDC2023-03-10
08033390173230TEMA ElbowLIMACORPORATE SPAJDC2023-03-10
08033390175449TEMA ElbowLIMACORPORATE SPAJDC2023-03-10
08033390175456TEMA ElbowLIMACORPORATE SPAJDC2023-03-10
08033390196802TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390196819TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390196826TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390196833TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390231435TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390231442TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390231459TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390126441TEMA ElbowLIMACORPORATE SPAJDC2023-01-25
10801902194647ARROWTELEFLEX INCORPORATEDJDC2022-11-08
00846832012459Latitude™ - ElbowTORNIER, INC.JDC2022-03-31
00846832012473Latitude™ - ElbowTORNIER, INC.JDC2022-03-31
07613327590050Axel Pin Assembly Standard ElbowHowmedica Osteonics Corp.JDC2022-03-23
07613327590074Bearing and Axle Bushing Assembly - Standard ElbowHowmedica Osteonics Corp.JDC2022-03-23
08033390151252TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390151269TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390151276TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390151283TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390151290TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390151306TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27