FDA.reportPublic FDA data

NA

Primary DI
00889024196407
Brand
NA
Company
Zimmer, Inc.
Model
00-5851-000-14
Published
2016-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KWLProsthesis, Hip, Hemi-, Femoral, Metal
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110940000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110940000ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMENZimmer, Inc.2011-07-01KRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024196407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024196407008890241964078890241964070889024196407

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024710580Custom Femoral Lateralizing ReamerSSI008673SSI0086732026-07-20
00889024711495Z1 ExtractorSSI008663SSI0086632026-07-20
00889024701281Identity® Shoulder System11007733110077332026-06-10
00889024701298Identity® Shoulder System11007734110077342026-06-10
00889024701304Identity® Shoulder System11007735110077352026-06-10
00889024701311Identity® Shoulder System11007736110077362026-06-10
00889024701328Identity® Shoulder System11007737110077372026-06-10
00889024701335Identity® Shoulder System11007738110077382026-06-10
00889024701342Identity® Shoulder System11007739110077392026-06-10
00889024701359Identity® Shoulder System11007740110077402026-06-10
00889024701366Identity® Shoulder System11007741110077412026-06-10
00889024701373Identity® Shoulder System11007742110077422026-06-10
00889024701380Identity® Shoulder System11007743110077432026-06-10
00889024701397Identity® Shoulder System11007744110077442026-06-10
00889024701403Identity® Shoulder System11007745110077452026-06-10
00889024701410Identity® Shoulder System11007746110077462026-06-10
00889024701427Identity® Shoulder System11007747110077472026-06-10
00889024701434Identity® Shoulder System11007748110077482026-06-10
00889024701441Identity® Shoulder System11007749110077492026-06-10
00889024701458Identity® Shoulder System11007750110077502026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04546540035523OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035523OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035523OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035714OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035790OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035790OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035790OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035806OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035806OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035806OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035813OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035813OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035813OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035820OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035820OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
04546540035820OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035837OmnifitHowmedica Osteonics Corp.LPH2015-09-24
04546540035837OmnifitHowmedica Osteonics Corp.JDI2015-09-24
04546540035837OmnifitHowmedica Osteonics Corp.LWJ2015-09-24
07613327016772UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016789UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016796UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016802UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016819UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016826UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016833UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016840UHRHowmedica Osteonics Corp.KWL2015-09-24
07613327016857UHRHowmedica Osteonics Corp.KWL2015-09-24