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 Pin, Fixation, Smooth
510(k) Number K012125
Device Name OPUS MAGNUM ANCHOR & INSERTER
Applicant
Opus Medical, Inc.
27127 Calle Arroyo, Suite 1924
San Juan Capistrano,  CA  92675
Applicant Contact MARK RITCHART
Correspondent
Opus Medical, Inc.
27127 Calle Arroyo, Suite 1924
San Juan Capistrano,  CA  92675
Correspondent Contact MARK RITCHART
Regulation Number888.3040
Classification Product Code
HTY  
Subsequent Product Code
MBI  
Date Received07/06/2001
Decision Date 09/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-