FDA.reportPublic FDA data

Wagner Cone Prosthesis®

Primary DI
00889024487765
Brand
Wagner Cone Prosthesis®
Company
Zimmer GmbH
Model
01.00569.011
Catalog number
01.00569.011
Device description
WAGNER CONE PROX. TRIAL STEM EXTRACTOR
Published
2017-03-08
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
HWTTEMPLATE
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
HWTTemplateOrthopedic1
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
00889024487765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024487765008890244877658890244877650889024487765

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

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
00889024298521Natural Nail®47-2487-002-0047-2487-002-002015-10-21
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
00840606191715Overwatch PCFSPINAL ELEMENTS, INC.HWT2026-07-31
00840311211470Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWT2026-07-30
00889024707467Z1® Hip SystemZimmer, Inc.KWZ2026-07-29
00889024707467Z1® Hip SystemZimmer, Inc.LZO2026-07-29
18257200103096ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103102ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103119ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103126ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103133ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103140ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103157ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103164ALLOGRAFT - CORTICALOrthofix US LLCHWT2026-07-17
18257200103522ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103539ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103546ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103553ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103560ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103577ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103584ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103591ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103607ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103614ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103782ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103799ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103805ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103812ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103829ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103836ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103843ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17
18257200103850ALLOQUENT - ALIFOrthofix US LLCHWT2026-07-17