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510(k) K132373

BIOMET ACCESS SYSTEM by Biomet Spine (Aka Ebi, LLC) — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2014
Date Received
July 30, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Nerve Locator
Device Class
Class II
Regulation Number
874.1820
Review Panel
NE
Submission Type

To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

Other clearances by Biomet Spine (Aka Ebi, LLC)

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  • K133746 — POLARIS SPINAL SYSTEM (March 12, 2014)
  • K131615 — POLARIS SPINAL SYSTEM (September 4, 2013)
  • K123549 — POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM (February 25, 2013)
  • K123451 — POLARIS SPINAL SYSTEM - BALLISTA II RODS (December 3, 2012)
  • K122989 — BIOMET LATERAL SPACER SYSTEM (October 24, 2012)
  • K122378 — NEXTGEN ALTIUS OCT SYSTEM (September 20, 2012)
  • K113593 — NEXTGEN ALTIUS OCT SYSTEM (April 17, 2012)
  • K110650 — ZYSTON ARC INTERBODY SPACER (June 30, 2011)

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