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510(k) K133746

POLARIS SPINAL SYSTEM by Biomet Spine (Aka Ebi, LLC) — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2014
Date Received
December 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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)
  • K132373 — BIOMET ACCESS SYSTEM (March 27, 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 NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)