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 Screw, Fixation, Bone
510(k) Number K233567
Device Name OsteoCoil™ Nitinol Compression System (Multiple Component PNs)
Applicant
Flower Orthopedics Corporation Dba Conventus Flower Ortho
100 Witmer Rd. Suite 280
Suite 280
Horsham,  PA  19044
Applicant Contact Christina Rovaldi
Correspondent
Flower Orthopedics Corporation Dba Conventus Flower
100 Witmer Rd. Suite 280
Suite 280
Horsham,  PA  19044
Correspondent Contact Christina Rovaldi
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/06/2023
Decision Date 11/22/2024
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
-
-