• 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 | Inspections

New Search Back To Search Results
Device Classification Name fastener, fixation, biodegradable, soft tissue
510(k) Number K120540
Device Name BIOBOLT
Original Applicant
1370 creekside blvd.
naples,  FL  34108 -1945
Original Contact courtney smith
Regulation Number888.3030
Classification Product Code
Subsequent Product Code
Date Received02/23/2012
Decision Date 03/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No