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510(k) K200642

OrthAlign Plus System by Orthalign, Inc. — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2020
Date Received
March 11, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Other clearances by Orthalign, Inc.

  • K242616 — Lantern® Hip (October 3, 2024)
  • K200892 — Harvey(R) Surgical Assistant (June 18, 2020)
  • K172462 — OrthAlign Plus System (November 22, 2017)
  • K171780 — OrthAlign Plus System (July 11, 2017)
  • K163379 — KneeAlign 2 System (March 2, 2017)
  • K162962 — OrthAlign Plus System (January 23, 2017)
  • K153237 — OrthAlign Plus System (March 1, 2016)
  • K140331 — ORTHALIGN PLUS SYSTEM (June 10, 2014)
  • K130387 — ORTHOALIGN PLUS SYSTEM (November 8, 2013)
  • K103829 — KNEEALIGN SYSTEM (April 4, 2011)

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  • K254148 — VERTICALE GPS Instruments (February 19, 2026)
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  • K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Upda (February 19, 2026)
  • K253381 — Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (February 12, 2026)
  • K252873 — Q Interbody Instruments (February 6, 2026)
  • K252058 — ROSA Knee System with UltraSound Imaging Platform (USIP) (February 6, 2026)
  • K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite (February 6, 2026)