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510(k) K220038

Camber Spine Navigation System by Camber Spine Technologies — Product Code OLO

K220038 is an FDA 510(k) premarket notification submitted by Camber Spine Technologies for the device "Camber Spine Navigation System". The FDA issued a decision of Substantially Equivalent on April 29, 2022. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Camber Spine Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2022
Date Received
January 5, 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 Camber Spine Technologies

  • K234077 — SPIRA® Anterior Lumbar Spacers (July 12, 2024)
  • K232256 — Alcantara Thoracolumbar Plate System (April 16, 2024)
  • K233972 — Camber Sacroiliac (SI) Fixation System (February 27, 2024)
  • K230942 — SPIRA® Posterior Lumbar Spacers (July 11, 2023)
  • K221324 — ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) (March 30, 2023)
  • K223837 — SPIRA®-C Integrated Fixation System (March 22, 2023)
  • K203503 — Camber Sacroiliac (SI) Fixation System (September 2, 2022)
  • K210595 — SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers (June 15, 2021)
  • K193153 — SPIRA-C Integrated Fixation System (April 24, 2020)
  • K191584 — FORTICO Anterior Cervical Fixation System (October 22, 2019)

Other clearances for product code OLO

  • K253921 — VERTICALE® Navigation Instruments (June 26, 2026)
  • K260480 — VELYS™ Robotic-Assisted Solution (June 25, 2026)
  • K260369 — Dynamis Robotic Surgical System (June 20, 2026)
  • K261665 — CORUS™ Navigation System-GN (June 18, 2026)
  • K260571 — SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments (June 2, 2026)
  • K261060 — Navigated LLIF Impactable Tracker (May 29, 2026)
  • K254157 — CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody (May 26, 2026)
  • K260329 — Ion-C Navigation Instruments (May 22, 2026)
  • K260582 — ROSA® Shoulder System (May 21, 2026)
  • K252880 — Pytheas Your Guided Trajectory (May 11, 2026)

FDA data resources