MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C

Device Classification Name

screw, fixation, bone

510(k) Number K071437
Device Name MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

Applicant Contact crystal dizol
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

Correspodent Contact crystal dizol
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 05/23/2007
Decision Date 09/12/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No