FDA.reportPublic FDA data

NA

Primary DI
00889024181007
Brand
NA
Company
Zimmer, Inc.
Model
9363-32-063
Published
2016-07-20
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
JDJMesh, surgical, acetabular, hip, prosthesis
KWAProsthesis, hip, semi-constrained (metal uncemented acetabular component)
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
JDJMesh, Surgical, Acetabular, Hip, ProsthesisGeneral, Plastic Surgery2
KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)Orthopedic3
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024181007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024181007008890241810078890241810070889024181007

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

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
00889024707467Z1® Hip System6117776126117776122026-07-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707467Z1® Hip SystemZimmer, Inc.LZO2026-07-29
00889024707467Z1® Hip SystemZimmer, Inc.LWJ2026-07-29
09348215185428Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185435Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185442Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185459Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185466Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185473Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185480Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185497Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185503Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185510Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185527Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185534Signature Magnum Acetabular CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185664Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185671Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185688Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185695Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185701Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185718Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185725Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185732Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185749Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185756Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185763Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
09348215185770Signature Magnum Trispike CupSIGNATURE ORTHOPAEDICS PTY LTDKWA2026-07-29
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLPH2026-07-09
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGLZO2026-07-09
04046964680878COREHIP EXTENDEDAesculap AGLZO2020-08-10
04046964681028COREHIP EXTENDEDAesculap AGLZO2020-08-10