FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stabilis SA Cervical Stand-Alone System (Various PNs)
K Number: K251735
·
Decision Jul 30, 2025
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
8
Review Days
54
Basic Information
- Device Name
- Stabilis SA Cervical Stand-Alone System (Various PNs)
- K Number
- K251735
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acuity Surgical Devices, LLC
- Date Received
- June 6, 2025
- Decision Date
- July 30, 2025
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Acuity Surgical Devices, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | Jun 2, 2025 | Substantially Equivalent |
| K243386 | Ventris Intervertebral Body Fusion Device | Apr 22, 2025 | Substantially Equivalent |
| K241413 | sagAlign Lumbar Cage System (Various PNs) | Jul 17, 2024 | Substantially Equivalent |
| K230639 | Align Cervical Interbody Fusion System | Dec 1, 2023 | Substantially Equivalent |
| K222561 | Align | Sep 23, 2022 | Substantially Equivalent |
| K221535 | Align Lumbar Interbody Fusion System | Jul 22, 2022 | Substantially Equivalent |
| K201671 | A-Link Z | May 4, 2021 | Substantially Equivalent |