510(k) K130387

ORTHOALIGN PLUS SYSTEM by Orthalign, Inc. — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 8, 2013
Date Received: February 15, 2013
Clearance Type: Traditional
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)
K200642 — OrthAlign Plus System (April 10, 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)
K103829 — KNEEALIGN SYSTEM (April 4, 2011)

Other clearances for product code OLO

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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)