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

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00889024506534Affixus® Natural Nail®1100356661100356662019-03-21
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00889024283695Dynesys®01.03710.6452016-03-14
00889024283701Dynesys®01.03711.1002016-03-14
00889024283718Dynesys®01.03711.2002016-03-14

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Primary DI, Brand, Company table
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00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
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00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
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00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01
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00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLZO2026-06-01