Vital™ Navigation System

FDA 510(k) K233443 · Zimvie Spine (Zimmer Biomet Spine, Inc.)

Substantially Equivalent

510(k) numberK233443

Submission

Device name
Vital™ Navigation System
Applicant
Zimvie Spine (Zimmer Biomet Spine, Inc.)
Westminister, CO, US
Received
October 19, 2023
Decision date
November 16, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OLO – Orthopedic Stereotaxic Instrument
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4560
Specialty
Neurology

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Other 510(k)s with product code OLO

510(k)DeviceApplicantDecision
K262506Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special Remex Medical Corp.08/20/2026SE
K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional Suite 201, National Innovation Centre07/30/2026SE
K261205SPINEART Navigation Instrument SystemOLO · Traditional Spineart SA07/29/2026SE
K262121Ion-L Navigated InstrumentsOLO · Special SurGenTec, LLC07/24/2026SE
K261024TMINI Miniature Robotic SystemOLO · Traditional THINK Surgical, Inc.07/24/2026SE
K261113Op.n™ Spine Navigation and Robotic GuidanceOLO · Traditional Ecential Robotics07/22/2026SE
K261852OTS HipOLO · Special Ortoma AB07/01/2026SE
K253921VERTICALE® Navigation InstrumentsOLO · Traditional Silony Medical GmbH06/26/2026SE
K260480VELYS™ Robotic-Assisted SolutionOLO · Traditional Depuy Ireland UC06/25/2026SE
K260369Dynamis Robotic Surgical SystemOLO · Traditional LEM Surgical AG06/20/2026SE

More from LEM Surgical AG

510(k)DeviceDecision
K240647Virage® Navigation SystemOLO · Special 04/05/2024SE
K240539Vital™ Spinal Fixation SystemNKB · Special 03/15/2024SE
K230116Vital™ Spinal Fixation SystemNKB · Traditional 10/11/2023SE

Questions and answers

When was Vital™ Navigation System cleared by the FDA?

Vital™ Navigation System (K233443) received a 510(k) decision of Substantially Equivalent on November 16, 2023, 28 days after the submission was received.

What is the product code of K233443?

The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.