FDA.reportPublic FDA data

PS CONSTRAINED INSERT XSM

Primary DI
08428898186064
Brand
PS CONSTRAINED INSERT XSM
Company
BIOMET SPAIN ORTHOPAEDICS SL
Model
178825
Catalog number
178825
Published
2016-03-11
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
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08428898186064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08428898186064084288981860648428898186064

GMDN Terms#

Term, Definition table
TermDefinition
Tibial insertAn implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)342-54543iPBG-CS@zimmerbiomet.com

Regulatory Flags#

DUNS number
460900553
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08428898185999PS CONSTRAINED INSERT MED1788601788602016-03-11
08428898186002PS CONSTRAINED INSERT MED1788621788622016-03-11
08428898186019PS CONSTRAINED INSERT MED1788651788652016-03-11
08428898186026PS CONSTRAINED INSERT MED1788681788682016-03-11
08428898186033PS CONSTRAINED INSERT MED1788721788722016-03-11
08428898186040PS CONSTRAINED INSERT XSM1788201788202016-03-11
08428898186057PS CONSTRAINED INSERT XSM1788221788222016-03-11
08428898186071PS CONSTRAINED INSERT XSM1788281788282016-03-11
08428898186088PS CONSTRAINED INSERT XSM1788321788322016-03-11
08428898186095PS CONSTRAINED INSERT SML1788401788402016-03-11
08428898186101PS CONSTRAINED INSERT SML1788421788422016-03-11
08428898186118PS CONSTRAINED INSERT SML1788451788452016-03-11
08428898186125PS CONSTRAINED INSERT SML1788481788482016-03-11
08428898186132PS CONSTRAINED INSERT SML1788521788522016-03-11
08428898186149PS CONSTRAINED INSERT LGE1788801788802016-03-11
08428898186156PS CONSTRAINED INSERT LGE1788821788822016-03-11
08428898186163PS CONSTRAINED INSERT LGE1788851788852016-03-11
08428898186170PS CONSTRAINED INSERT LGE1788881788882016-03-11
08428898186187PS CONSTRAINED INSERT LGE1788921788922016-03-11
08428898186194PS CONSTRAINED INSERT XLG1789001789002016-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001257SurgiCase PlannerMaterialise NVJWH2026-05-28
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07613327000108INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
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07613327000146INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000153INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000160INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
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07613327000238INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000245INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
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07613327000306INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000337INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000405INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000467INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327000597INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327010107INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327010114INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327010121INSTRUMENTHowmedica Osteonics Corp.JWH2016-09-24
07613327013511TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013528TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013542TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013559TriathlonHowmedica Osteonics Corp.JWH2015-09-24
07613327013573TriathlonHowmedica Osteonics Corp.JWH2015-09-24