FDA.reportPublic FDA data

Vario-Cup System

Primary DI
04026575352784
Brand
Vario-Cup System
Company
WALDEMAR LINK GmbH & Co. KG
Model
99-0055/42
Catalog number
99-0055/42
Device description
Vario-Cup, ID22 OD42
Published
2022-08-03
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
K221794000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221794000Vario-Cup SystemWaldemar Link GmbH & Co. KG2022-07-20KWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026575352784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026575352784040265753527844026575352784

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
00193982895006TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
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00193982895044TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895303TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895310TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14