Zimmer Biomet Universal Navigation System
FDA 510(k) K192133 · Zimmer Biomet Spine, Inc.
510(k) numberK192133
Submission
- Device name
- Zimmer Biomet Universal Navigation System
- Applicant
- Zimmer Biomet Spine, Inc.
Westminister, CO, US - Received
- August 7, 2019
- Decision date
- October 29, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special | Remex Medical Corp. | 08/20/2026SE |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional | Suite 201, National Innovation Centre | 07/30/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | Spineart SA | 07/29/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | SurGenTec, LLC | 07/24/2026SE |
| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | THINK Surgical, Inc. | 07/24/2026SE |
| K261113 | Op.n Spine Navigation and Robotic GuidanceOLO · Traditional | Ecential Robotics | 07/22/2026SE |
| K261852 | OTS HipOLO · Special | Ortoma AB | 07/01/2026SE |
| K253921 | VERTICALE® Navigation InstrumentsOLO · Traditional | Silony Medical GmbH | 06/26/2026SE |
| K260480 | VELYS Robotic-Assisted SolutionOLO · Traditional | Depuy Ireland UC | 06/25/2026SE |
| K260369 | Dynamis Robotic Surgical SystemOLO · Traditional | LEM Surgical AG | 06/20/2026SE |
More from LEM Surgical AG
| 510(k) | Device | Decision |
|---|---|---|
| K212023 | Virage Navigation SystemOLO · Traditional | 08/27/2021SE |
| K203218 | CaP Spheres Pellet PackMQV · Traditional | 05/04/2021SE |
| K210275 | Polaris Spinal SystemNKB · Special | 04/02/2021SE |
| K203507 | Vitality® Spinal Fixation SystemNKB · Traditional | 01/28/2021SE |
| K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…KWQ · Traditional | 10/08/2020SE |
| K191722 | Vital Navigation SystemOLO · Traditional | 12/02/2019SE |
| K190556 | Zimmer Biomet Universal Navigation SystemOLO · Traditional | 10/24/2019SE |
| K183550 | Vitality® Spinal Fixation SystemNKB · Traditional | 04/08/2019SE |
| K181096 | Avenue P Cage SystemOVD · Traditional | 01/15/2019SE |
| K180227 | Polaris Spinal Growth SystemPGM · Traditional | 03/15/2018SE |
Questions and answers
When was Zimmer Biomet Universal Navigation System cleared by the FDA?
Zimmer Biomet Universal Navigation System (K192133) received a 510(k) decision of Substantially Equivalent on October 29, 2019, 83 days after the submission was received.
What is the product code of K192133?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.