FDA.reportPublic FDA data

Paxeon Femoral Head

Primary DI
08177570200139
Brand
Paxeon Femoral Head
Company
PAXEON RECONSTRUCTION LLC
Model
PR111-152-613
Device description
Paxeon Head, Ceramic Size 28mm L
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
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
08177570200139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08177570200139081775702001398177570200139

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods#

Method table
Method

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
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
08177570200207Paxeon Femoral HeadPR111-152-6332016-12-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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