FDA.reportPublic FDA data

BI-AXIAL™ ELBOW SYSTEM

Primary DI
00880304820913
Brand
BI-AXIAL™ ELBOW SYSTEM
Company
Biomet Orthopedics, LLC
Model
CP562351
Catalog number
CP562351
Published
2016-05-05
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980428000BIOMET BIAXIAL TOTAL ELBOWBiomet, Inc.1998-05-05JDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304820913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304820913008803048209138803048209130880304820913

GMDN Terms#

Term, Definition table
TermDefinition
Hinged total elbow prosthesisA sterile implantable artificial substitute for an elbow joint designed to replace the articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes humeral and ulnar components, typically with parts made of metal and polyethylene (PE), that form a hinge at articulation. The device may include fixation devices (e.g., screws) for implantation and may be implanted with or without bone cement.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868561368VersaNail®2810-13-0372810130372023-09-07
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

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