MERETE 3.0 AND 3.5 MM LOCKING SCREWS


Device Classification Name

screw, fixation, bone

510(k) Number K081513
Device Name MERETE 3.0 AND 3.5 MM LOCKING SCREWS
Applicant
MERETE MEDICAL GMBH
49 purchase street
rye, 
NY 
10580

Applicant Contact jorg mietzner
Correspondent
MERETE MEDICAL GMBH
49 purchase street
rye, 
NY 
10580

Correspodent Contact jorg mietzner
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 05/30/2008
Decision Date 07/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No