FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Spinal Elements Navigated Instruments
K Number: K190881
·
Decision Dec 19, 2019
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
49
Review Days
259
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Spinal Elements Navigated Instruments
- K Number
- K190881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinal Elements, Inc.
- Date Received
- April 4, 2019
- Decision Date
- December 19, 2019
- Product Code
- OLO
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OLO), ordered by most recent decision date.
Dynamis Robotic Surgical System
FDA 510(k)
FDA Class 2
·Neurology
CORUS Navigation System-GN
FDA 510(k)
FDA Class 2
·Neurology
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
Navigated LLIF Impactable Tracker
FDA 510(k)
FDA Class 2
·Neurology
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
FDA 510(k)
FDA Class 2
·Neurology
Ion-C Navigation Instruments
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Spinal Elements, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260506 | Ventana® P/T Lumbar Interbody System | May 15, 2026 | Substantially Equivalent |
| K253559 | Ventana A Anterior Lumbar Interbody System | Feb 25, 2026 | Substantially Equivalent |
| K250773 | Luna® Ti Interbody Fusion System | Feb 4, 2026 | Substantially Equivalent |
| K242527 | The Karma® Fixation System | May 21, 2025 | Substantially Equivalent |
| K243916 | Primus Spinal Fixation System | Feb 21, 2025 | Substantially Equivalent |
| K231593 | Sapphire X3 Anterior Cervical Plate System | Aug 2, 2023 | Substantially Equivalent |
| K231252 | Ventana L Spinal System | Jun 30, 2023 | Substantially Equivalent |
| K222833 | Ventana C Spinal System | May 19, 2023 | Substantially Equivalent |
| K222516 | Mercury® II Spinal System | Dec 1, 2022 | Substantially Equivalent |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System | Jun 30, 2021 | Substantially Equivalent |