Choice Spine Navigation System
FDA 510(k) K182721 · Choicespine, LP
510(k) numberK182721
Submission
- Device name
- Choice Spine Navigation System
- Applicant
- Choicespine, LP
Knoxville, TN, US - Received
- September 28, 2018
- Decision date
- January 8, 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 |
|---|---|---|
| K190227 | Boomerang Anterior Cervical Plate SystemKWQ · Traditional | 05/01/2019SE |
| K183397 | ChoiceSpine Stealth Cervical Spacer SystemODP · Special | 03/06/2019SE |
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemMQP · Special | 02/22/2019SE |
| K183214 | Raven Lumbar Plate SystemKWQ · Traditional | 01/03/2019SE |
| K180519 | HARRIER-SA Lumbar Interbody SystemOVD · Traditional | 05/16/2018SE |
| K172816 | TiGer Shark SystemMAX · Traditional | 01/26/2018SE |
| K173215 | Choice Spine Laminoplasty Fixation SystemNQW · Traditional | 01/19/2018SE |
| K171489 | Acapella Cervical Spacer SystemOVE · Traditional | 10/23/2017SE |
| K171686 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemMQP · Traditional | 09/15/2017SE |
| K171456 | Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw SystemsNKB · Traditional | 08/03/2017SE |
Questions and answers
When was Choice Spine Navigation System cleared by the FDA?
Choice Spine Navigation System (K182721) received a 510(k) decision of Substantially Equivalent on January 8, 2019, 102 days after the submission was received.
What is the product code of K182721?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.