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510(k) K002677

NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM by Nuvasive, Inc. — Product Code BXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2000
Date Received
August 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Ac-Powered
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type

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Other clearances for product code BXM

  • K013215 — MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (October 16, 2001)
  • K921498 — VER MED A10011 PNS DUAL ELEMENT ELECTRODE (June 9, 1993)
  • K870662 — MODEL SKCK STERILE KNOB COVER KIT (October 28, 1987)