FDA.reportPublic FDA data

MANZA HOLE COVER

Primary DI
00841176102415
Brand
MANZA HOLE COVER
Company
STINSON ORTHOPEDICS INC.
Model
104-00-000
Catalog number
104-00-000
Device description
MANZA APICAL HOLE COVER
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
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
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
K121297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121297000ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULARSignature Orthopaedics Pty, Ltd.2012-12-28LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841176102415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841176102415008411761024158411761024150841176102415

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis hole plugA sterile implantable device designed as a threaded or non-threaded plug intended to fill any hole of the shell component of a two-piece acetabulum prosthesis (shell and liner). It is made of metallic or polymer material, and is screwed or pushed into the hole after the implantation of the shell component.

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
00841176100541MANZA HA NON-CEMENTED CUP101-00-040101-00-0402016-12-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812142InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812180InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812197InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812203InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812210InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812227InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812234InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812241InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812258InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812265InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812272InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812289InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812296InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812319InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812326InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812333InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01