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510(k) K220291

NEXXT SPINE NAVIGATION System by Nexxt Spine, LLC — Product Code OLO

K220291 is an FDA 510(k) premarket notification submitted by Nexxt Spine, LLC for the device "NEXXT SPINE NAVIGATION System". The FDA issued a decision of Substantially Equivalent on March 31, 2022. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Nexxt Spine, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2022
Date Received
February 1, 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 Nexxt Spine, LLC

  • K243838 — NEXXT MATRIXX® SI System (March 14, 2025)
  • K240690 — STRUXXURE® MCS Anterior Cervical Plate System (March 22, 2024)
  • K231799 — INERTIA® CONNEXX™ Modular Pedicle Screw System (July 20, 2023)
  • K221905 — INERTIA CONNEXX Modular Pedicle Screw System (July 28, 2022)
  • K202230 — NEXXT MATRIXX Stand Alone ALIF System (December 15, 2020)
  • K202192 — STRUXXURE®-L and STRUXXURE®-A Plate System (September 17, 2020)
  • K200969 — NEXXT MATRIXX System (May 21, 2020)
  • K200543 — NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (March 23, 2020)
  • K193412 — NEXXT MATRIXX System (February 24, 2020)
  • K193370 — Nexxt Matrixx System (January 21, 2020)

Other clearances for product code OLO

  • K262506 — Remex Spine Surgery Navigation - Universal Instruments (August 20, 2026)
  • K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registr (July 30, 2026)
  • K261205 — SPINEART Navigation Instrument System (July 29, 2026)
  • K261024 — TMINI Miniature Robotic System (July 24, 2026)
  • K262121 — Ion-L Navigated Instruments (July 24, 2026)
  • K261113 — Op.n™ Spine Navigation and Robotic Guidance (July 22, 2026)
  • K261852 — OTS Hip (July 1, 2026)
  • K253921 — VERTICALE® Navigation Instruments (June 26, 2026)
  • K260480 — VELYS™ Robotic-Assisted Solution (June 25, 2026)
  • K260369 — Dynamis Robotic Surgical System (June 20, 2026)

FDA data resources