Black Diamond Navigation Instruments
FDA 510(k) K192495 · Osseus Fusion Systems
510(k) numberK192495
Submission
- Device name
- Black Diamond Navigation Instruments
- Applicant
- Osseus Fusion Systems
Dallas, TX, US - Received
- September 11, 2019
- Decision date
- January 17, 2020
- 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 |
|---|---|---|
| K223413 | Pisces-SA STANDALONE ALIF Interbody SystemOVD · Traditional | 02/10/2023SE |
| K222107 | Black Diamond POCT Spinal SystemNKG · Traditional | 11/03/2022SE |
| K213935 | PISCES-SA Standalone ALIF Interbody SystemOVD · Traditional | 05/06/2022SE |
| K213590 | Blue Topaz Sacroiliac Screw SystemOUR · Traditional | 03/01/2022SE |
| K192121 | Black Diamond Pedicle Screw SystemNKB · Traditional | 10/29/2019SE |
| K181347 | Aries® Lumbar InterbodiesMAX · Traditional | 08/15/2018SE |
| K170844 | Gemini-C Hybrid Cervical Interbody SystemODP · Traditional | 07/03/2017SE |
| K160522 | White Pearl Preferred Angle Anterior Cervical PlateKWQ · Traditional | 04/26/2016SE |
| K131810 | Osseus Black Diamond Pedicle Screw SystemMNH · Traditional | 08/08/2013SE |
Questions and answers
When was Black Diamond Navigation Instruments cleared by the FDA?
Black Diamond Navigation Instruments (K192495) received a 510(k) decision of Substantially Equivalent on January 17, 2020, 128 days after the submission was received.
What is the product code of K192495?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.