FDA.report

PROFIX

Primary DI
03596010221452
Brand
PROFIX
Company
Smith & Nephew, Inc.
Model
71508249
Catalog number
71508249
Device description
PRO CONFORMING PLUS TIBIAL INSERT LEFT SZ4 35MM
Published
2015-08-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KWHPROSTHESIS, TOE, CONSTRAINED, POLYMER

Product Code Classifications

CodeDeviceSpecialtyClass
KWHProsthesis, Toe, Constrained, PolymerOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010221452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010221452035960102214523596010221452

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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00885556884034NA74038835740388352026-02-20
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