FDA.reportPublic FDA data

DISCOVERY ELBOW SYSTEM

Primary DI
00880304215900
Brand
DISCOVERY ELBOW SYSTEM
Company
Biomet Orthopedics, LLC
Model
114944
Catalog number
114944
Published
2015-10-24
Public version status
Update
Distribution status
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
JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304215900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304215900008803042159008803042159000880304215900

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated elbow humerus prosthesisA sterile implantable device designed to replace the distal humerus as part of an elbow joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24
00880304434370Vanguard® Knee System1842811842812015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08033390151313TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27