FDA.reportPublic FDA data

PRELUDE PF

Primary DI
00880304567702
Brand
PRELUDE PF
Company
Biomet Sports Medicine, LLC
Model
110005118
Catalog number
110005118
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRRPROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123907000PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,Biomet Manufacturing Corp2013-09-03KRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304567702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304567702008803045677028803045677020880304567702

GMDN Terms#

Term, Definition table
TermDefinition
Patellofemoral joint prosthesisA sterile implantable device designed to replace the patellofemoral articulating surface of the knee to treat isolated patellofemoral disease, typically osteoarthritis. The device is made of metal (e.g., oxidized zirconium alloy) and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; it may include fixation devices (e.g., pegs) for implantation which 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
627100159
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304000674MINI HARPOON9029229029222015-10-24
00880304001145HARPOON9029209029202015-10-24
00880304002586TITANIUM INTERFERENCE SCREW9068919068912015-10-24
00880304002821HARPOON9029299029292015-10-24
00880304007048BIO-PHASE II9055029055022015-10-24
00880304008298TI SCREW ES9025549025542015-10-24
00880304008434TI SCREW ES9025569025562015-10-24
00880304009028TITANIUM INTERFERENCE SCREW9096949096942015-10-24
00880304011168TITANIUM INTERFERENCE SCREW9068929068922015-10-24
00880304011175TITANIUM INTERFERENCE SCREW9096489096482015-10-24
00880304116511BONE MULCHCP550800CP5508002015-10-24
00880304117303TITANIUM INTERFERENCE SCREWCP909580CP9095802015-10-24
00880304117310TITANIUM INTERFERENCE SCREWCP909581CP9095812015-10-24
00880304117358TITANIUM INTERFERENCE SCREWCP909585CP9095852015-10-24
00880304404663MINI HARPOON9029239029232015-10-24
00880304405363POLY SUTURE BUTTON9042159042152015-10-24
00880304405387POLY SUTURE BUTTON9042199042192015-10-24
00880304405974NO-PROFILE9045309045302015-10-24
00880304405981NO-PROFILE9045359045352015-10-24
00880304405998NO-PROFILE9045409045402015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327127423INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127447INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127461INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127478INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127492INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127508INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127515INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127522INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.KRR2017-11-24
07613327049305AvonHowmedica Osteonics Corp.KRR2017-06-19
00888867106697Arthrex®ARTHREX, INC.KRR2017-02-15
07613154557431INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051186INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051209INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24
07613327127546INSTRUMENTHowmedica Osteonics Corp.KRR2016-09-24