• 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 neurosurgical nerve locator
Regulation Description Surgical nerve stimulator/locator.
Definition To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
Product CodePDQ
Regulation Number 874.1820
Device Class 2


Premarket Reviews
ManufacturerDecision
CADWELL
  SUBSTANTIALLY EQUIVALENT 1
KOROS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEUROVISION MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 2
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
TEDAN SURGICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False negative result 1
Failure to sense 1
No Known Device Problem 1
Total Device Problems 3

-
-