• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back To Search Results
Device Classification Name prosthesis, shoulder, hemi-, humeral, metallic uncemented
510(k) Number K112983
Device Name SPACER-S
Original Applicant
7 trail house court
rockville,  MD  20850
Original Contact christine brauer
Regulation Number888.3690
Classification Product Code
Subsequent Product Code
Date Received10/06/2011
Decision Date 12/12/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes