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 Screw, Fixation, Intraosseous
510(k) Number K042573
Device Name KLS MARTIN DRILL-FREE MMF SCREW
Applicant
KLS-Martin L.P.
1239-1 St. John'S Ind. Pkwy.
South
Jacksonville,  FL  32246
Applicant Contact JENNIFER DAMATO
Correspondent
KLS-Martin L.P.
1239-1 St. John'S Ind. Pkwy.
South
Jacksonville,  FL  32246
Correspondent Contact JENNIFER DAMATO
Regulation Number872.4880
Classification Product Code
DZL  
Date Received09/21/2004
Decision Date 10/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-