KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K030368
Device Name KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe 5th floor
culver city, 
CA 
90230 -7600

Applicant Contact mario t marcelo
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe 5th floor
culver city, 
CA 
90230 -7600

Correspodent Contact mario t marcelo
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 02/04/2003
Decision Date 03/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No