FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIRION Lateral Lumbar Interbody System
K Number: K223335
·
Decision May 9, 2023
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
21
Review Days
189
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Basic Information
- Device Name
- SIRION Lateral Lumbar Interbody System
- K Number
- K223335
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Astura Medical
- Date Received
- November 1, 2022
- Decision Date
- May 9, 2023
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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FDA 510(k)
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Other Clearances by Astura Medical
| K Number | Device Name | ||
|---|---|---|---|
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Jan 22, 2026 | Substantially Equivalent |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Oct 21, 2025 | Substantially Equivalent |
| K243259 | MASADA Modular Spinal Fixation System | Jan 7, 2025 | Substantially Equivalent |
| K240160 | EGPS Navigated Instruments | Oct 17, 2024 | Substantially Equivalent |
| K233359 | DOMINION Expandable Corpectomy System | Mar 8, 2024 | Substantially Equivalent |
| K231694 | MASADA Modular Spinal Fixation System | Nov 16, 2023 | Substantially Equivalent |
| K232211 | REUNION Sacroiliac Joint Fusion System | Oct 24, 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 |