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, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K192071
Device Name iNSitu Total Hip System
Applicant
Theken Companies, LLC
1800 Triplett Blvd.
Akron,  OH  44306
Applicant Contact Garrett Spurgeon
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-L'Ile Perrot,  CA J7V 7P2
Correspondent Contact Robert A. Poggie
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
LZO   OQG   OQI  
Date Received08/02/2019
Decision Date 08/30/2019
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
-
-