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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K241875
Device Name TheRay Collared and Collarless Femoral Stem
Applicant
Nextstep Arthropedix
1800 Triplett Blvd.
Akron,  OH  44306
Applicant Contact Garrett Spurgeon
Correspondent
Nextstep Arthropedix
1800 Triplett Blvd.
Akron,  OH  44306
Correspondent Contact Garrett Spurgeon
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWY   LPH   LZO   OQG   OQI  
Date Received06/28/2024
Decision Date 09/13/2024
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
-
-