FDA.report

SMF, STIKTITE

Primary DI
03596010619587
Brand
SMF, STIKTITE
Company
Smith & Nephew, Inc.
Model
71352502
Catalog number
71352502
Device description
SMF STEM WITH STIKTITE SZ 2
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

Product Codes

CodeName
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications

CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions

SubmissionSupplement
K080625000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K080625000SMITH & NEPHEW MIS HIP STEM WITH STIKTITESmith & Nephew, Inc.2008-05-08LPH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010619587PrimaryGS10

GMDN Terms

TermDefinition
Press-fit femoral stem prosthesisA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
045483575
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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