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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, INC.)
  SUBSTANTIALLY EQUIVALENT 1
SI-BONE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEGUARD, S.A.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 7
Device Alarm System 5
Failure to Read Input Signal 4
Break 3
Deflation Problem 2
Monitor 2
False Negative Result 1
Appropriate Term/Code Not Available 1
Failure to Sense 1
Needle 1
Total Device Problems 27


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