EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS


Device Classification Name

prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

510(k) Number K080980
Device Name EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Applicant Contact xavier sarabia
Correspondent
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Correspodent Contact xavier sarabia
Regulation Number 888.3353
Classification Product Code
MEH  
Date Received 04/07/2008
Decision Date 05/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No