FDA.reportPublic FDA data

P.F.C. SIGMA

Primary DI
10603295250029
Brand
P.F.C. SIGMA
Company
DEPUY ORTHOPAEDICS, INC.
Model
96-7508
Catalog number
967508
Device description
P.F.C. SIGMA TIBIAL TRAY FIXED BEARING KEEL TITANIUM POROCOAT 4
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
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991106000P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAYDePuy Orthopaedics, Inc.1999-06-09JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295250029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329525002910603295250029

GMDN Terms#

Term, Definition table
TermDefinition
Coated knee tibia prosthesisA sterile implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr)] and is coated with a material (e.g., beads, hydroxyapatite, mesh) intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and the femoral prosthetic component of the knee joint and its implantation may be performed with or without bone cement.

Contacts#

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

Regulatory Flags#

DUNS number
080506581
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295553588ATTUNE2999-67-0282999670282026-08-26
10603295553595ATTUNE2999-67-0292999670292026-08-26
10603295553601ATTUNE2999-67-0302999670302026-08-26
10603295553618ATTUNE2999-67-0312999670312026-08-26
10603295552680ATTUNE2999670062999670062026-05-29
10603295555001ATTUNE2999-67-0492999670492026-05-29
10603295555018ATTUNE2999-67-0502999670502026-05-29
10603295555025ATTUNE2999-67-0512999670512026-05-29
10603295555032ATTUNE2999-67-0522999670522026-05-29
10603295555049ATTUNE2999-67-0532999670532026-05-29
10603295555056ATTUNE2999-67-0542999670542026-05-29
10603295555544ATTUNE2999-67-0842999670842026-05-29
10603295555582ATTUNE2999-67-0852999670852026-05-29
10603295015154DURALOC1220-28-1481220281482015-09-24
10603295015161DURALOC1220-28-1501220281502015-09-24
10603295015178DURALOC1220-28-1521220281522015-09-24
10603295015185DURALOC1220-28-1541220281542015-09-24
10603295015192DURALOC1220-28-1561220281562015-09-24
10603295015208DURALOC1220-28-1581220281582015-09-24
10603295015215DURALOC1220-28-1601220281602015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906067247247Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247254Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247261Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247278Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247285Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247292Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247308Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247315Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247322Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247339Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247346Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247353Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247360Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247377Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247384Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247391Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247407Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247414Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247421Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247438Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247445Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247452Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247469Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247476Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247483Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247490Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247506Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247513Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247520Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247537Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05