• 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) | 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 pin, fixation, resorbable, hard tissue
Regulation Description Smooth or threaded metallic bone fixation fastener.
Definition Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.
Product CodeOVZ
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 2
Migration of device or device component 1
Material integrity issue 1
No Information 1
Difficult to deploy 1
Total Device Problems 6

-
-