• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K051083
Device Name ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM
Original Applicant
ACUMED LLC
5885 nw cornelius pass rd.
hillsboro,  OR  97124 9432
Original Contact ed boehmer
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/27/2005
Decision Date 05/12/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-