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 Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K191297
Device Name iNSitu Bipolar Hip System
Applicant
Theken Companies, LLC
1800 Triplett Blvd.
Akron,  OH  44306
Applicant Contact Garrett Spurgeon
Correspondent
Biovera
65 Promenade Saint-Louis
Notre-Dame-De-L’Ile-Perrot,  CA J7V 7P2
Correspondent Contact Bob Poggie
Regulation Number888.3390
Classification Product Code
KWY  
Date Received05/14/2019
Decision Date 09/17/2019
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
Recalls CDRH Recalls
-
-