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

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device external mandibular fixator and/or distractor
Regulation Description Bone plate.
Product CodeMQN
Regulation Number 872.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 11
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
NEWMEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 7
SYNTHES
  SUBSTANTIALLY EQUIVALENT 13
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Break 1
Total Device Problems 1

-
-