• 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 filler, bone void, calcium compound
510(k) Number K190371
Device Name Morpheus-C
Biogennix, LLC.
1641 McGaw Ave
irvine,  CA  92614
Applicant Contact timothy bumbalough
Paladin Medical, Inc.
PO Box 560
stillwater,  MN  55082
Correspondent Contact elaine duncan
Regulation Number888.3045
Classification Product Code
Date Received02/15/2019
Decision Date 08/09/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No