FDA.reportPublic FDA data

Wagner Cone Prosthesis®

Primary DI
00889024282476
Brand
Wagner Cone Prosthesis®
Company
Zimmer GmbH
Model
01.00569.124
Catalog number
01.00569.124
Device description
WAGNER CONE PROST. TRIAL STEM DISTAL Ø24
Published
2016-09-24
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
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS 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
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113556000WAGNER CONE PROSTHESIS SYSTEMZimmer GmbH2012-02-17LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024282476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024282476008890242824768890242824760889024282476

GMDN Terms#

Term, Definition table
TermDefinition
Femoral stem prosthesis trialA copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter24Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
488133448
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868453120Avenir®01.08000.01201.08000.0122021-02-25
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00889024298538Natural Nail®47-2487-002-0547-2487-002-052015-10-21
00889024298545Natural Nail®47-2487-002-1047-2487-002-102015-10-21
00889024298552Natural Nail®47-2487-002-1547-2487-002-152015-10-21
00889024292512NCB®02.02261.0132024-05-03
00889024292550NCB®02.02261.1132024-05-03
00889024296558NCB®02.03156.0902024-05-03
00889024296565NCB®02.03156.0952024-05-03
00889024296572NCB®02.03156.1002024-05-03
00889024506503Affixus® Natural Nail®1100356641100356642019-03-21
00889024506510Affixus® Natural Nail®1100372371100372372019-03-21
00889024506527Affixus® Natural Nail®1100356651100356652019-03-21
00889024506534Affixus® Natural Nail®1100356661100356662019-03-21
00889024506558Affixus® Natural Nail®1100356681100356682019-03-21
00889024277038Dynesys® Top-Loading System01.03956.4502015-10-16
00889024283688Dynesys®01.03710.0062015-10-16
00889024283695Dynesys®01.03710.6452016-03-14
00889024283701Dynesys®01.03711.1002016-03-14
00889024283718Dynesys®01.03711.2002016-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896619United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-21
04719886896619United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-21
04719886896626United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-21
04719886896626United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-09-21
07630345706584M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706584M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21
07630345706591M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21
07630345706591M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706607M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706607M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21
07630345706614M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706614M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21
07630345706621M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706621M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21
07630345706638M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706638M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21
07630345706645M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706645M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21
07630345706652M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21
07630345706652M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706669M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21
07630345706669M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706676M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706676M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21
07630345706683M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21
07630345706683M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706690M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706690M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21
07630345706706M-Vizion Femoral Revision System ExtensionMedacta International SAKWZ2026-09-21
07630345706706M-Vizion Femoral Revision System ExtensionMedacta International SALZO2026-09-21