FDA.reportPublic FDA data

Versacem Acetabular Shell and Double Mobility HC Liners

Primary DI
07630030808449
Brand
Versacem Acetabular Shell and Double Mobility HC Liners
Company
Medacta International SA
Model
01.27.56CMB
Device description
Versacem Metalback Ø56 mm
Published
2025-03-20
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
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241767000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241767000Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.2025-03-06LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630030808449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630030808449076300308084497630030808449

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630030883576Mpact 3D Metal Foam25070.2236HC2026-09-04
07630030883583Mpact 3D Metal Foam25070.2238HC2026-09-04
07630030883590Mpact 3D Metal Foam25070.2240HC2026-09-04
07630030883606Mpact 3D Metal Foam25070.2242HC2026-09-04
07630030883613Mpact 3D Metal Foam25070.2244HC2026-09-04
07630030883620Mpact 3D Metal Foam25070.2246HC2026-09-04
07630030883637Mpact 3D Metal Foam25070.2248HC2026-09-04
07630030883644Mpact 3D Metal Foam25070.2250HC2026-09-04
07630030883651Mpact 3D Metal Foam25070.2252HC2026-09-04
07630030883668Mpact 3D Metal Foam25070.2254HC2026-09-04
07630030883675Mpact 3D Metal Foam25070.2256HC2026-09-04
07630030883682Mpact 3D Metal Foam25070.2258HC2026-09-04
07630030883699Mpact 3D Metal Foam25070.2840HC2026-09-04
07630030883705Mpact 3D Metal Foam25070.2842HC2026-09-04
07630030883712Mpact 3D Metal Foam25070.2844HC2026-09-04
07630030883729Mpact 3D Metal Foam25070.2846HC2026-09-04
07630030883736Mpact 3D Metal Foam25070.2848HC2026-09-04
07630030883743Mpact 3D Metal Foam25070.2850HC2026-09-04
07630030883750Mpact 3D Metal Foam25070.2852HC2026-09-04
07630030883767Mpact 3D Metal Foam25070.2854HC2026-09-04

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629032064LineageMicroport Orthopedics Inc.LZO2026-08-18
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00192629032057LineageMicroport Orthopedics Inc.LZO2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
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00193982895037TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.LZO2026-08-14
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
10885862022448NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.LZO2022-09-19
10885862029867NAExactech, Inc.LZO2022-09-19