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 apparatus, traction, non-powered
Regulation Description Nonpowered orthopedic traction apparatus and accessories.
Product CodeHST
Regulation Number 888.5850
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
FERNO-WASHINGTON
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 8
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Issue 2
No Known Device Problem 1
Total Device Problems 3

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 1 0 0 2
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Allen Medical Systems, Inc. II Mar-18-2013
2 Linvatec Corp. dba ConMed Linvatec II Oct-21-2009
3 Stryker Endoscopy II May-14-2010
4 Zimmer, Inc. II Jun-14-2013

-
-