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510(k) K132373

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

K132373 is an FDA 510(k) premarket notification submitted by Biomet Spine (Aka Ebi, LLC) for the device "BIOMET ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent on March 27, 2014. The device falls under product code PDQ (Neurosurgical Nerve Locator), a Class II device regulated under 21 CFR 874.1820. Biomet Spine (Aka Ebi, LLC) has at least 10 other 510(k) clearances on record.

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)

  • K133518 — MAXAN ANTERIOR CERVICAL PLATE SYSTEM (November 5, 2014)
  • K140710 — BIOMET GRAFT DELIVERY SYRINGES (September 4, 2014)
  • 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)

Other clearances for product code PDQ

  • K260992 — iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 (June 25, 2026)
  • K253580 — Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, (April 26, 2026)
  • K243636 — Neuralytix iD3 System (NTX-9001) (June 26, 2025)
  • K223438 — TELIGEN System Peripheral Motor Nerve Stimulation Indications (February 10, 2023)
  • K221821 — ATEC IOM Accessory Instruments (September 23, 2022)
  • K220160 — PediGuard Threaded (March 31, 2022)
  • K203684 — Neurosign V4 Intraoperative Nerve Monitor (March 17, 2021)
  • K201454 — DSG Connect Technology (February 10, 2021)
  • K191723 — ATEC IOM Accessory Instruments (October 18, 2019)
  • K190163 — ALARA Neuro Access Kit (July 16, 2019)

FDA data resources