FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORUS Navigation System-GX
K Number: K251060
·
Decision Jul 30, 2025
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
21
Review Days
117
Basic Information
- Device Name
- CORUS Navigation System-GX
- K Number
- K251060
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Providence Medical Technology, Inc.
- Date Received
- April 4, 2025
- Decision Date
- July 30, 2025
- 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 |
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Other Clearances by Providence Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K261665 | CORUS Navigation System-GN | Jun 18, 2026 | Substantially Equivalent |
| K253676 | CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D) | May 14, 2026 | Substantially Equivalent |
| K253190 | CORUS-LX Implant | Nov 20, 2025 | Substantially Equivalent |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Jul 10, 2025 | Substantially Equivalent |
| K241035 | PMT Posterior Cervical Stabilization System (PCSS) | Jun 25, 2024 | Substantially Equivalent |
| K240625 | CORUS Navigation Access System | May 3, 2024 | Substantially Equivalent |
| K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Dec 19, 2023 | Substantially Equivalent |
| K230297 | PMT Expandable Cage (PMT EXP) | Aug 11, 2023 | Substantially Equivalent |
| K220951 | PMT Facet Fixation System (PMT FFS) | Dec 9, 2022 | Substantially Equivalent |
| K212636 | CORUS Spinal System-X | Oct 15, 2021 | Substantially Equivalent |