FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIGEL 3DR Anterior Cervical Interbody Fusion System
K Number: K200685
·
Decision Jun 11, 2020
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
24
Review Days
87
Basic Information
- Device Name
- RIGEL 3DR Anterior Cervical Interbody Fusion System
- K Number
- K200685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MiRus, LLC
- Date Received
- March 16, 2020
- Decision Date
- June 11, 2020
- Product Code
- ODP
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
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| K232481 | RIGEL 3DR Anterior Cervical Corpectomy System | Oct 13, 2023 | Substantially Equivalent |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | Sep 11, 2023 | Substantially Equivalent |
| K230369 | EUROPA Navigated Instruments | Jun 23, 2023 | Substantially Equivalent |
| K220441 | CYGNUS MoRe Anterior Cervical Plate System | Sep 16, 2022 | Substantially Equivalent |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System | May 13, 2022 | Substantially Equivalent |