510(k) K213876

Spineology Navigation Instruments by Spineology, Inc. — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 5, 2022
Date Received: December 13, 2021
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.

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K192047 — Rampart One Lumbar Interbody Fusion System (August 23, 2019)
K191091 — Rampart One Lumbar Interbody Fusion System (May 23, 2019)
K190055 — Duo Lumbar Interbody Fusion Device (March 7, 2019)
K182322 — Duo Lumbar Interbody Fusion Device (October 24, 2018)

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