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 Filler, Bone Void, Calcium Compound
510(k) Number K212083
Device Name Tactoset Injectable Bone Substitute
Applicant
Anika Therapeutics, Inc.
32 Wiggins Ave.
Beford,  MA  01730
Applicant Contact Wei Zhao
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
32 Wiggins Ave.
Beford,  MA  01730
Correspondent Contact Wei Zhao
Regulation Number888.3045
Classification Product Code
MQV  
Date Received07/02/2021
Decision Date 08/31/2021
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
-
-