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 plate, fixation, bone
510(k) Number K122623
Device Name SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT
Applicant
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
386 BEECH AVENUE
UNIT B6
TORRANCE,  CA  90501
Applicant Contact ALLYSON PARKS
Correspondent
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
386 BEECH AVENUE
UNIT B6
TORRANCE,  CA  90501
Correspondent Contact ALLYSON PARKS
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/28/2012
Decision Date 09/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-