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 Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K121890
Device Name GENESYS PRESSFT SUTURE ANCHOR
Applicant
Linvatec Corporation D/B/A Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact LORNA K LINVILLE
Correspondent
Linvatec Corporation D/B/A Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact LORNA K LINVILLE
Regulation Number888.3030
Classification Product Code
MAI  
Date Received06/28/2012
Decision Date 08/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-