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510(k) K013215

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2001
Date Received
September 26, 2001
Clearance Type
Special
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

  • K002677 — NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (November 13, 2000)
  • K921498 — VER MED A10011 PNS DUAL ELEMENT ELECTRODE (June 9, 1993)
  • K870662 — MODEL SKCK STERILE KNOB COVER KIT (October 28, 1987)