FDA.reportPublic FDA data

Vario-Cup System

Primary DI
04026575329939
Brand
Vario-Cup System
Company
WALDEMAR LINK GmbH & Co. KG
Model
107-230/65
Published
2023-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K781735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K781735000ENDOPROSTHESIS SYSTEM, VARIO-HEADWaldemar Link GmbH & Co. KG1978-10-24KWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575329939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575329939040265753299394026575329939

GMDN Terms#

Term, Definition table
TermDefinition
Bipolar femoral head outer component, hemiarthroplastyAn implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and an inner polyethylene (PE) liner.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315675488
Device count
1
DM exempt
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04026575448678MobileLink Acetabular Cup System183-353/40183-353/402026-07-09
04026575448685MobileLink Acetabular Cup System183-363/40183-363/402026-07-09
04026575448760MobileLink Acetabular Cup System183-354/40183-354/402026-07-09
04026575448777MobileLink Acetabular Cup System183-355/40183-355/402026-07-09
04026575448784MobileLink Acetabular Cup System183-356/40183-356/402026-07-09
04026575448791MobileLink Acetabular Cup System183-364/40183-364/402026-07-09
04026575448807MobileLink Acetabular Cup System183-365/40183-365/402026-07-09
04026575448814MobileLink Acetabular Cup System183-366/40183-366/402026-07-09
04026575448821MobileLink Acetabular Cup System183-373/40183-373/402026-07-09
04026575448838MobileLink Acetabular Cup System183-374/40183-374/402026-07-09
04026575448845MobileLink Acetabular Cup System183-375/40183-375/402026-07-09
04026575448852MobileLink Acetabular Cup System183-376/40183-376/402026-07-09
04026575448869MobileLink Acetabular Cup System183-743/40183-743/402026-07-09
04026575448876MobileLink Acetabular Cup System183-744/40183-744/402026-07-09
04026575448883MobileLink Acetabular Cup System183-745/40183-745/402026-07-09
04026575448890MobileLink Acetabular Cup System183-746/40183-746/402026-07-09
04026575348213SPII Model Lubinus128-950/35128-950/352015-11-01
04026575348220SPII Model Lubinus128-951/35128-951/352015-11-01
04026575348237SPII Model Lubinus128-952/35128-952/352015-11-01
04026575348244SPII Model Lubinus128-953/35128-953/352015-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011453476REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWY2026-06-01
00850011453483REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWY2026-06-01
00850011453490REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWY2026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWY2026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWY2026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWY2026-06-01
07611996118674POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142327POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142334POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142341POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142358POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142372POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996074901SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095586SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095593SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095616SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095630SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095647SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19