FDA.report

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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications

CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024181007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024181007008890241810078890241810070889024181007

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags

DUNS number
056038268
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00887868150333Affixus®8151103008151103002026-03-19
00887868150340Affixus®8151103208151103202026-03-19
00887868150357Affixus®8151103408151103402026-03-19
00887868150364Affixus®8151103608151103602026-03-19
00887868150371Affixus®8151103808151103802026-03-19
00887868150388Affixus®8151104008151104002026-03-19
00887868150395Affixus®8151104208151104202026-03-19
00887868150401Affixus®8151114208151114202026-03-19
00887868150555Affixus®8151123008151123002026-03-19
00887868150562Affixus®8151123208151123202026-03-19
00887868150579Affixus®8151123408151123402026-03-19
00887868150586Affixus®8151123608151123602026-03-19
00887868150593Affixus®8151123808151123802026-03-19
00887868150609Affixus®8151124008151124002026-03-19
00887868150616Affixus®8151124208151124202026-03-19
00887868150883Affixus®8151113208151113202026-03-19
00887868150890Affixus®8151113408151113402026-03-19
00887868150906Affixus®8151113608151113602026-03-19
00887868150913Affixus®8151113808151113802026-03-19

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04719886912951Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912968Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912975Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912982Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912999Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913002Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913019Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913026Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913033Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913040Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913064Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
00889024703292OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCJDI2025-12-02
00889024703315OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCJDI2025-12-02
00889024703339OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCJDI2025-12-02
10885862658210EXACTECHExactech, Inc.JDI2025-11-14
10885862658326EXACTECHExactech, Inc.JDI2025-11-14
04719872162568UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872162926UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872169017UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872169024UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872169031UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
00810008120859LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23
00810008120866LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23
00810008120873LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23
00810008120880LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23