APTUS CANNULATED COMPRESSION SCREWS


Device Classification Name

screw, fixation, bone

510(k) Number K110658
Device Name APTUS CANNULATED COMPRESSION SCREWS
Applicant
MEDARTIS AG
11234 el camino real,
suite 200
san diego, 
CA 
92130

Applicant Contact kevin a thomas
Correspondent
MEDARTIS AG
11234 el camino real,
suite 200
san diego, 
CA 
92130

Correspodent Contact kevin a thomas
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 03/07/2011
Decision Date 06/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No