Camber Spine Navigation System
FDA 510(k) K220038 · Camber Spine Technologies
510(k) numberK220038
Submission
- Device name
- Camber Spine Navigation System
- Applicant
- Camber Spine Technologies
King Of Prussia, PA, US - Received
- January 5, 2022
- Decision date
- April 29, 2022
- 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 |
|---|---|---|
| K234077 | SPIRA® Anterior Lumbar SpacersMAX · Traditional | 07/12/2024SE |
| K232256 | Alcantara Thoracolumbar Plate SystemKWQ · Traditional | 04/16/2024SE |
| K233972 | Camber Sacroiliac (SI) Fixation SystemOUR · Traditional | 02/27/2024SE |
| K230942 | SPIRA® Posterior Lumbar SpacersMAX · Traditional | 07/11/2023SE |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)OVD · Traditional | 03/30/2023SE |
| K223837 | SPIRA®-C Integrated Fixation SystemOVE · Traditional | 03/22/2023SE |
| K203503 | Camber Sacroiliac (SI) Fixation SystemOUR · Traditional | 09/02/2022SE |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersMAX · Traditional | 06/15/2021SE |
| K193153 | SPIRA-C Integrated Fixation SystemOVE · Traditional | 04/24/2020SE |
| K191584 | FORTICO Anterior Cervical Fixation SystemKWQ · Traditional | 10/22/2019SE |
Questions and answers
When was Camber Spine Navigation System cleared by the FDA?
Camber Spine Navigation System (K220038) received a 510(k) decision of Substantially Equivalent on April 29, 2022, 114 days after the submission was received.
What is the product code of K220038?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.