FDA.reportPublic FDA data

CPT®

Primary DI
00889024145788
Brand
CPT®
Company
Zimmer, Inc.
Model
8114-02-10
Catalog number
00-8114-002-10
Published
2015-09-24
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191735000
K960658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191735000CPT Hip SystemZimmer, Inc.2020-03-20JDI
K960658000COLLARLESS POLISHED TAPER HIP PROSTHESISZimmer, Inc.1996-07-16JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024145788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024145788008890241457888890241457880889024145788

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated hip femur prosthesis, one-pieceA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is one-piece and is not coated with materials intended to improve fixation and stability. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation 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)348-2759zimmer.consumerrelations@zimmer.com
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00889024701465Identity® Shoulder System11007751110077512026-06-10
00889024701472Identity® Shoulder System11007752110077522026-06-10

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00810068850185Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
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00810068850284Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
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00810068850642Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
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00810068850710Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850727Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850734Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850741Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850758Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850772Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850895Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26