FDA.report

GENESIS II

Primary DI
03596010469199
Brand
GENESIS II
Company
Smith & Nephew, Inc.
Model
71421013
Catalog number
71421013
Device description
GENESIS II OXINIUM P/S FEMORAL LT SZ 3
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
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
K962557000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K962557000GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTSmith & Nephew Richards, Inc.1996-12-05JWH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010469199PrimaryGS10

GMDN Terms

TermDefinition
Unicondylar knee prosthesisA sterile artificial substitute for the bearing surface of only one femoral condyle and corresponding tibial condyle of the knee (medial or lateral condyle) implanted during primary or revision knee replacement. It typically consists of femoral and tibial components and a knee insert which are made of metal or polyethylene (PE); fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. The device is indicated in unicompartmental disease and/or damage (e.g., from arthritis) to the bearing surfaces of the knee.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+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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