Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name screw, fixation, bone
510(k) Number K030848
Device Name PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
Applicant
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact PAUL S LEE
Correspondent
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
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
-
-