FDA.reportPublic FDA data

MANZA HA NON-CEMENTED CUP

Primary DI
00841176100541
Brand
MANZA HA NON-CEMENTED CUP
Company
STINSON ORTHOPEDICS INC.
Model
101-00-040
Catalog number
101-00-040
Device description
MANZA HA NON-CEMENTED CUP NO HOLE, 40MM
Published
2016-12-26
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
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153131000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153131000Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular LinerSignature Orthopaedics Pty, Ltd.2016-06-03MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841176100541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841176100541008411761005418411761005410841176100541

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellA sterile, 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
080460688
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841176102118MANZA SCREWS104-65-015104-65-0152016-12-26
00841176102125MANZA SCREWS104-65-020104-65-0202016-12-26
00841176102132MANZA SCREWS104-65-025104-65-0252016-12-26
00841176102149MANZA SCREWS104-65-030104-65-0302016-12-26
00841176102156MANZA SCREWS104-65-035104-65-0352016-12-26
00841176102163MANZA SCREWS104-65-040104-65-0402016-12-26
00841176102170MANZA SCREWS104-65-045104-65-0452016-12-26
00841176102187MANZA SCREWS104-65-050104-65-0502016-12-26
00841176102194MANZA SCREWS104-65-055104-65-0552016-12-26
00841176102200MANZA SCREWS104-65-060104-65-0602016-12-26
00841176102392MANZA SCREWS104-65-065104-65-0652016-12-26
00841176102408MANZA SCREWS104-65-070104-65-0702016-12-26
00841176100558MANZA HA NON-CEMENTED CUP101-00-042101-00-0422016-12-26
00841176100565MANZA HA NON-CEMENTED CUP101-00-044101-00-0442016-12-26
00841176100572MANZA HA NON-CEMENTED CUP101-00-046101-00-0462016-12-26
00841176100589MANZA HA NON-CEMENTED CUP101-00-048101-00-0482016-12-26
00841176100596MANZA HA NON-CEMENTED CUP101-00-050101-00-0502016-12-26
00841176100602MANZA HA NON-CEMENTED CUP101-00-052101-00-0522016-12-26
00841176100619MANZA HA NON-CEMENTED CUP101-00-054101-00-0542016-12-26
00841176100626MANZA HA NON-CEMENTED CUP101-00-056101-00-0562016-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630030883576Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883583Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883590Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883606Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883613Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883620Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883637Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883644Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883651Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883668Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883675Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883682Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883699Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883705Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883712Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883729Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883736Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883743Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883750Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883767Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883774Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883781Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883798Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883804Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883811Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883828Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883835Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883842Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883859Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883866Mpact 3D Metal FoamMedacta International SALPH2026-09-04