• 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 show TPLC since Back to Search Results
Device intraoperative orthopedic joint assessment aid
Regulation Description Stereotaxic instrument.
Definition Measurement and interpretation of orthopedic joint information.
Product CodeONN
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
ORTHOSENSOR, INC.
  SUBSTANTIALLY EQUIVALENT 4

Recalls
Manufacturer Recall Class Date Posted
1 Orthosensor, Inc. II Oct-05-2018
2 Orthosensor, Inc. II Jan-29-2015

-
-