SLIC SCREW REPAIR SYSTEM


Device Classification Name

screw, fixation, bone

510(k) Number K111608
Device Name SLIC SCREW REPAIR SYSTEM
Applicant
ACUMED LLC
1331 h street nw
12th floor
washington, 
DC 
20005

Applicant Contact hollace rhodes
Correspondent
ACUMED LLC
1331 h street nw
12th floor
washington, 
DC 
20005

Correspodent Contact hollace rhodes
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 06/09/2011
Decision Date 08/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No