KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT


Device Classification Name

prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer

510(k) Number K111970
Device Name KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
Applicant
TORNIER
161 rue lavoisier
montbonnot
saint-ismier cedex, 

FR

38334

Applicant Contact stephanie bernard
Correspondent
TORNIER
161 rue lavoisier
montbonnot
saint-ismier cedex, 

FR

38334

Correspodent Contact stephanie bernard
Regulation Number 888.3540
Classification Product Code
KRR  
Date Received 07/11/2011
Decision Date 02/23/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No