MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER


Device Classification Name

screw, fixation, bone

510(k) Number K073054
Device Name MODIFICATION TO APERFIX FEMORAL IMPLANT WITH INSERTER
Applicant
CAYENNE MEDICAL, INC.
11234 el camino real
suite 200
san diego, 
CA 
92130

Applicant Contact david j collette
Correspondent
CAYENNE MEDICAL, INC.
11234 el camino real
suite 200
san diego, 
CA 
92130

Correspodent Contact david j collette
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 10/30/2007
Decision Date 11/27/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No