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Polaris Spinal System

by Biomet Spine (Aka Ebi, LLC) 2 variants

510(k) K133746

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK133746 Date12 Mar 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2152-2015 FDA Class II initiated 12 Mar 2015

    Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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