FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPIC Deformity Band System
K Number: K222097
·
Decision May 4, 2023
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
36
Applicant Total
21
Review Days
290
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Basic Information
- Device Name
- OLYMPIC Deformity Band System
- K Number
- K222097
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Astura Medical
- Date Received
- July 18, 2022
- Decision Date
- May 4, 2023
- Product Code
- OWI
- 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 |
|---|---|---|---|
| OWI | Bone Fixation Cerclage, Sublaminar | FDA class 2 | Orthopedic |
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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 |
| 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 |