FDA.report

JOURNEY

Primary DI
03596010627384
Brand
JOURNEY
Company
Smith & Nephew, Inc.
Model
71422352
Catalog number
71422352
Device description
JOURNEY UNI OXINIUM FIXED BEARING FEMORAL SIZE 2 RIGHT MEDIAL/LEFT LATERAL
Published
2015-08-30
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
HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions

SubmissionSupplement
K073175000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K073175000JOURNEY UNICONDYLAR FEMORAL IMPLANTSmith & Nephew, Inc.2007-12-20HSX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010627384PrimaryGS10

GMDN Terms

TermDefinition
Uncoated unicondylar knee femur prosthesisA sterile implantable device designed to replace the bearing surface of one femoral condyle (femoral component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device articulates with a tibial component and an insert, 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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00885556787786NA74034136740341362026-02-20
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00885556884140NA74038846740388462026-02-20

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