FDA.reportPublic FDA data

P.F.C.

Primary DI
10603295215219
Brand
P.F.C.
Company
DEPUY INTERNATIONAL LTD
Model
85-7725
Catalog number
857725
Device description
P.F.C. TOTAL HIP SYSTEM ACETABULAR LINER 28mm 10 DEGREES 60-64mm
Published
2015-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K873585000
K902137000
K930712000
K931189000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K873585000POROUS COATED ACETABULAR CUPJohnson & Johnson Professionals, Inc.1987-10-28JDI
K902137000P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENTJohnson & Johnson Orthopaedics, Inc.1990-06-26JDI
K930712000P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULARJohnson & Johnson Orthopaedics, Inc.1993-10-04LZO
K931189000P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACETJohnson & Johnson Orthopaedics, Inc.1994-02-09LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295215219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329521521910603295215219

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
896498813
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295155492SIGMA2960-08-4002960084002018-09-24
10603295155508SIGMA2960-09-4002960094002018-09-24
10603295210320NA8555-06-0008555060002018-09-24
10603295119708AML234-52-10002345210002018-09-24
10603295224341NA9505-01-0329505010322018-09-24
10603295224792LCS9505-01-1199505011192018-09-24
10603295226581PATHWAY9505-01-5229505015222018-09-24
10603295226598NA9505-01-5239505015232018-09-24
10603295226604NA9505-01-5249505015242018-09-24
10603295241065CHARNLEY9620-73-0009620730002018-09-24
10603295026853NA1299-01-0291299010292016-06-30
10603295026952NA1299-01-0581299010582018-09-24
10603295147657C-STEM2580-00-0342580000342018-09-24
10603295147664C-STEM2580-00-0352580000352018-09-24
10603295147671C-STEM2580-00-0362580000362018-09-24
10603295147688C-STEM2580-00-0372580000372018-09-24
10603295147695C-STEM2580-00-0382580000382018-09-24
10603295147701C-STEM2580000392580000392018-09-24
10603295147718C-STEM2580000402580000402018-09-24
10603295147725C-STEM2580000412580000412018-09-24

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