510(k) K182345

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 21, 2018
Date Received: August 28, 2018
Clearance Type: Special
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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K210155 — Duo Expandable Interbody Fusion System (February 19, 2021)
DEN200010 — Spineology Interbody Fusion System (September 18, 2020)
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)

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