FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CORUS-LX Implant
K Number: K253190
·
Decision Nov 20, 2025
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
77
Applicant Total
21
Review Days
55
Basic Information
- Device Name
- CORUS-LX Implant
- K Number
- K253190
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Providence Medical Technology, Inc.
- Date Received
- September 26, 2025
- Decision Date
- November 20, 2025
- Product Code
- MRW
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | FDA unclassified | Unknown |
Similar 510(k) Clearances
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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 |
| K251060 | CORUS Navigation System-GX | Jul 30, 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 |