S-COMP Reform® POCT Navigation Instruments
FDA 510(k) K231229 · Precision Spine, Inc.
510(k) numberK231229
Submission
- Device name
- S-COMP Reform® POCT Navigation Instruments
- Applicant
- Precision Spine, Inc.
Pear, MS, US - Received
- April 28, 2023
- Decision date
- May 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K242297 | Reform Pedicle Screw SystemNKB · Traditional | 12/17/2024SE |
| K220862 | E-GPS Navigated InstrumentsOLO · Traditional | 07/14/2022SE |
| K213118 | Dakota ALIF SystemOVD · Traditional | 04/01/2022SE |
| K220324 | AccuFit Lateral 2-Hole PlateKWQ · Traditional | 03/16/2022SE |
| K212075 | ShurFit Lumbar Interbody SystemMAX · Traditional | 12/08/2021SE |
| K212937 | Dakota ALIF Plate SystemKWQ · Traditional | 11/04/2021SE |
| K203129 | NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemOVE · Traditional | 01/12/2021SE |
| K200303 | Reform Pedicle Screw SystemNKB · Traditional | 05/19/2020SE |
| K192494 | NexGen Anterior Cervical Plate SystemKWQ · Traditional | 10/29/2019SE |
Questions and answers
When was S-COMP Reform® POCT Navigation Instruments cleared by the FDA?
S-COMP Reform® POCT Navigation Instruments (K231229) received a 510(k) decision of Substantially Equivalent on May 25, 2023, 27 days after the submission was received.
What is the product code of K231229?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.