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 K201561
Device Name Membrane Screws and Membrane Tacks
Applicant
Neoss Limited
Windsor House, Cornwall Rd
Harrogate,  GB HG1 2PW
Applicant Contact Stellan Sundstrom
Correspondent
M Squared Associates, Inc
127 West 30th St Floor 9
New York,  NY  10001
Correspondent Contact Cherita James
Regulation Number872.4880
Classification Product Code
DZL  
Date Received06/10/2020
Decision Date 10/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-