FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOMINION Expandable Corpectomy System
K Number: K233359
·
Decision Mar 8, 2024
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
21
Review Days
161
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Basic Information
- Device Name
- DOMINION Expandable Corpectomy System
- K Number
- K233359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Astura Medical
- Date Received
- September 29, 2023
- Decision Date
- March 8, 2024
- Product Code
- MQP
- 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 |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K243259 | MASADA Modular Spinal Fixation System | Jan 7, 2025 | Substantially Equivalent |
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| K232211 | REUNION Sacroiliac Joint Fusion System | Oct 24, 2023 | Substantially Equivalent |
| K223335 | SIRION Lateral Lumbar Interbody System | May 9, 2023 | Substantially Equivalent |
| K222097 | OLYMPIC Deformity Band System | May 4, 2023 | Substantially Equivalent |
| K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Jan 19, 2023 | Substantially Equivalent |
| K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion System | Mar 30, 2022 | Substantially Equivalent |