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 Rod, Fixation, Intramedullary And Accessories
510(k) Number K100112
Device Name SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)
Applicant
Sonoma Orthopedic Products, Inc.
650 Larkfield Center
Suite C
Santa Rosa,  CA  95403
Applicant Contact CARLOS GONZALEZ
Correspondent
Sonoma Orthopedic Products, Inc.
650 Larkfield Center
Suite C
Santa Rosa,  CA  95403
Correspondent Contact CARLOS GONZALEZ
Regulation Number888.3020
Classification Product Code
HSB  
Date Received01/14/2010
Decision Date 09/28/2010
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
-
-