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, Hip, Hemi-, Femoral, Metal
510(k) Number K062273
Device Name SPACER-G TEMPORARY HIP PROSTHESIS
Applicant
Tecres S.P.A.
2320 NW 66th Ct.
Gainesville,  FL  32653
Applicant Contact AMNON TALMOR
Correspondent
Tecres S.P.A.
2320 NW 66th Ct.
Gainesville,  FL  32653
Correspondent Contact AMNON TALMOR
Regulation Number888.3360
Classification Product Code
KWL  
Subsequent Product Code
KWY  
Date Received08/07/2006
Decision Date 05/22/2008
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
-
-