FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORUS Spinal System
K Number: K190201
·
Decision Mar 8, 2019
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
669
Applicant Total
9
Review Days
32
Basic Information
- Device Name
- CORUS Spinal System
- K Number
- K190201
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Providence Medical Technology, Inc.
- Date Received
- February 4, 2019
- Decision Date
- March 8, 2019
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Providence Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K212636 | CORUS Spinal System-X | Oct 15, 2021 | Substantially Equivalent |
| K183589 | PMT Facet Screw | Oct 11, 2019 | Substantially Equivalent |
| K180876 | DTRAX Spinal System | May 18, 2018 | Substantially Equivalent |
| K172279 | PMT Posterior Fixation System | Sep 20, 2017 | Substantially Equivalent |
| K170698 | ALLY(TM) Bone Screws | May 31, 2017 | Substantially Equivalent |