FDA.reportPublic FDA data

Paxeon Logical

Primary DI
08177570201693
Brand
Paxeon Logical
Company
PAXEON RECONSTRUCTION LLC
Model
PR111-12-9001
Device description
Central Hole Cover
Published
2016-12-14
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

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
08177570201693PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08177570201693081775702016938177570201693

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.

Regulatory Flags#

DUNS number
080437990
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
08177570201709Paxeon Logical PR111-12-91152016-12-14
08177570201716Paxeon Logical PR111-12-91202016-12-14
08177570201723Paxeon Logical PR111-12-91252016-12-14
08177570201747Paxeon Logical PR111-12-91352016-12-14
08177570201754Paxeon Logical PR111-12-91402016-12-14
08177570201761Paxeon Logical PR111-12-91452016-12-14
08177570201778Paxeon Logical PR111-12-91502016-12-14
08177570201785Paxeon Logical PR111-12-91552016-12-14
08177570201792Paxeon Logical PR111-12-91602016-12-14
08177570201808Paxeon Logical PR111-12-91652016-12-14
08177570201815Paxeon Logical PR111-12-91702016-12-14
08177570200115Paxeon Femoral HeadPR111-152-6112016-12-14
08177570200122Paxeon Femoral HeadPR111-152-6122016-12-14
08177570200139Paxeon Femoral HeadPR111-152-6132016-12-14
08177570200146Paxeon Femoral HeadPR111-152-6212016-12-14
08177570200153Paxeon Femoral HeadPR111-152-6222016-12-14
08177570200160Paxeon Femoral HeadPR111-152-6232016-12-14
08177570200177Paxeon Femoral HeadPR111-152-6242016-12-14
08177570200184Paxeon Femoral HeadPR111-152-6312016-12-14
08177570200191Paxeon Femoral HeadPR111-152-6322016-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899177United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899184United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899191United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899207United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899214United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899221United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899238United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899245United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899252United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886910896United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886913361Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886913378Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886913385Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886913392Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886913408Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15