FDA.report

JOURNEY

Primary DI
03596010554574
Brand
JOURNEY
Company
Smith & Nephew, Inc.
Model
74023111
Catalog number
74023111
Device description
JOURNEY ARTICULAR INSERT BCS SMALL 1-2 RIGHT 9MM
Published
2015-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions

SubmissionSupplement
K042515000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K042515000SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEESmith & Nephew, Inc.2005-03-14JWH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010554574PrimaryGS10

GMDN Terms

TermDefinition
Uncoated knee tibia prosthesis, polyethyleneAn 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 entirely of polyethylene (PE) and is not coated with a material 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 is intended to be performed with bone cement.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00885556884140NA74038846740388462026-02-20

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