Streamline Navigated Instruments
FDA 510(k) K200095 · Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
510(k) numberK200095
Submission
- Device name
- Streamline Navigated Instruments
- Applicant
- Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
Marquette, MI, US - Received
- January 16, 2020
- Decision date
- June 26, 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 |
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| K201497 | EVOS Cabling SystemJDQ · Traditional | 10/28/2020SE |
| K200513 | DAC Dynamic Active Compression PlateHRS · Traditional | 07/22/2020SE |
| K193468 | Tritium Sternal Cable Plate SystemJDQ · Traditional | 03/12/2020SE |
| K192800 | Streamline TL Spinal Fixation SystemNKB · Traditional | 01/14/2020SE |
| K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyMAX · Traditional | 12/20/2019SE |
| K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs:…MAX · Traditional | 07/05/2019SE |
| K183060 | CervAlign Anterior Cervical Plate SystemKWQ · Traditional | 01/17/2019SE |
| K172139 | Streamline OCT Occipito-Cervico-Thoracic SystemNKG · Traditional | 08/18/2017SE |
| K170830 | Unison-C Anterior Cervical Fixation SystemOVE · Traditional | 06/28/2017SE |
| K161876 | Tritium® Sternal Cable Plate SystemJDQ · Special | 09/09/2016SE |
Questions and answers
When was Streamline Navigated Instruments cleared by the FDA?
Streamline Navigated Instruments (K200095) received a 510(k) decision of Substantially Equivalent on June 26, 2020, 162 days after the submission was received.
What is the product code of K200095?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.