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 Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
510(k) Number K112983
Device Name SPACER-S
Applicant
Tecres S.P.A.
7 Trl. House Ct.
Rockville,  MD  20850
Applicant Contact CHRISTINE BRAUER
Correspondent
Tecres S.P.A.
7 Trl. House Ct.
Rockville,  MD  20850
Correspondent Contact CHRISTINE BRAUER
Regulation Number888.3690
Classification Product Code
HSD  
Subsequent Product Code
KWS  
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
Predetermined Change
Control Plan Authorized		 No
-
-