FDA.reportPublic FDA data

Bipolar Heads

Primary DI
07630030843754
Brand
Bipolar Heads
Company
Medacta International SA
Model
25060.2852
Device description
Ø28x52
Published
2014-11-18
Public version status
Update
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
K091967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091967000MEDACTA BIPOLAR HEADMedacta International S.A.2010-03-02KWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630030843754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630030843754076300308437547630030843754

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head bipolar componentA sterile 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., titanium alloy) and an inner polyethylene (PE) liner; it is typically used for older femoral fracture patients.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982895006TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
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