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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K030848
Device Name PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
Applicant
Karl Storz Endoscopy
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact PAUL S LEE
Correspondent
Karl Storz Endoscopy
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact PAUL S LEE
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/17/2003
Decision Date 06/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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