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, Nondegradable, Soft Tissue
510(k) Number K202355
Device Name Stryker Omega PEEK Knotless Anchor System
Applicant
Stryker
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact Katie Farraro
Correspondent
Stryker
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact Katie Farraro
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/19/2020
Decision Date 11/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-