Skip to content

Solanas Posterior Stabilization System

by Alphatec Spine, Inc. 2 variants

510(k) K131119

Solanas Posterior Stabilization System is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K131119 on 21 May 2013, active as of 22 Oct 2026. One FDA recall is linked to it.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK131119 Date21 May 2013ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-2092-2014 FDA Class II initiated 26 Jun 2014

    Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use.

Timeline

2 dated events

  1. Cleared FDA 510(k) K131119
  2. Recall initiated FDA recalls Z-2092-2014

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Other devices from Alphatec Spine, Inc.

See all devices from Alphatec Spine, Inc. →