FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CD Horizon Spinal System
K Number: K211596
·
Decision Jun 23, 2021
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
33
Review Days
30
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
- CD Horizon Spinal System
- K Number
- K211596
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic
- Date Received
- May 24, 2021
- Decision Date
- June 23, 2021
- 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 Medtronic
| K Number | Device Name | ||
|---|---|---|---|
| K253530 | Trexon Monofilament Synthetic Absorbable Suture | May 28, 2026 | Substantially Equivalent |
| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | Jan 16, 2026 | Substantially Equivalent |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | Aug 7, 2024 | Substantially Equivalent |
| K240190 | MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated | Feb 23, 2024 | Substantially Equivalent |
| K223494 | CD Horizon Spinal System | Jan 23, 2023 | Substantially Equivalent |
| K223178 | SelectSite C304 Deflectable Catheter System, C315 Delivery System | Nov 8, 2022 | Substantially Equivalent |
| K222873 | Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system | Nov 7, 2022 | Substantially Equivalent |
| K221244 | CD Horizon Spinal System | May 25, 2022 | Substantially Equivalent |
| K203111 | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System | Sep 16, 2021 | Substantially Equivalent |
| K210637 | CD Horizon Spinal System | Apr 30, 2021 | Substantially Equivalent |