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510(k) K223301

ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System by Spinecraft, LLC — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2023
Date Received
October 27, 2022
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 Spinecraft, LLC

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  • K211935 — ORIO-Ti Intervertebral Body Fusion Cage System (September 30, 2021)
  • K211323 — ASTRA Spine System (June 3, 2021)
  • K181350 — ASTRA-OCT Spine System (July 6, 2018)
  • K143683 — APEX-DL Spine System (May 22, 2015)
  • K150417 — ASTRA SPINE SYSTEM (May 19, 2015)
  • K131521 — VELOX ANTERIOR CERVICAL PLATE SYSTEM (December 24, 2013)
  • K132603 — APEX SPINE SYSTEM (November 20, 2013)
  • K110906 — APEX SPINE SYSTEM (July 26, 2011)

Other clearances for product code OLO

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  • K254148 — VERTICALE GPS Instruments (February 19, 2026)
  • K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For U (February 19, 2026)
  • 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)