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 K091156
Device Name TRIMED STERILE PRODUCT
Applicant
TriMed, Inc.
28337 Maitland Ln.
Saugus,  CA  91350
Applicant Contact KELLI ANDERSON
Correspondent
TriMed, Inc.
28337 Maitland Ln.
Saugus,  CA  91350
Correspondent Contact KELLI ANDERSON
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTY   HWC   JDS   MBI   NDL  
Date Received04/21/2009
Decision Date 07/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-