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 Component, Traction, Invasive
510(k) Number K920117
Device Name HALO ESPRIT
Applicant
Itm Corp.
1000 Burnett Ave.
Suite 250
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Itm Corp.
1000 Burnett Ave.
Suite 250
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3040
Classification Product Code
JEC  
Date Received01/13/1992
Decision Date 10/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-