FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Align Cervical Interbody Fusion System
K Number: K230639
·
Decision Dec 1, 2023
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
8
Review Days
268
Basic Information
- Device Name
- Align Cervical Interbody Fusion System
- K Number
- K230639
- 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
- March 8, 2023
- Decision Date
- December 1, 2023
- 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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Other Clearances by Acuity Surgical Devices, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Jul 30, 2025 | Substantially Equivalent |
| 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 |
| 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 |