FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
K Number: K232530
·
Decision Sep 18, 2023
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
17
Review Days
28
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Basic Information
- Device Name
- Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
- K Number
- K232530
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nexus Spine, LLC
- Date Received
- August 21, 2023
- Decision Date
- September 18, 2023
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Nexus Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K243934 | Stable-L Lumbar Interbody System | Apr 30, 2025 | Substantially Equivalent |
| K241467 | Stable-C Interbody System | Jul 17, 2024 | Substantially Equivalent |
| K233375 | Tranquil-L Interbody System | Mar 20, 2024 | Substantially Equivalent |
| K240416 | Tranquil-C Interbody System | Mar 12, 2024 | Substantially Equivalent |
| K233234 | PressON Spinal Fixation System | Oct 26, 2023 | Substantially Equivalent |
| K231486 | Stable-L Standalone Lumbar Interbody System | Oct 12, 2023 | Substantially Equivalent |
| K231763 | Stable-C Interbody System | Aug 21, 2023 | Substantially Equivalent |
| K223529 | PressON Spinal Fixation System | May 2, 2023 | Substantially Equivalent |
| K223627 | PreView-III Anterior Cervical Plate System | Feb 2, 2023 | Substantially Equivalent |
| K212498 | Stable-L Standalone Lumbar Interbody System | Mar 18, 2022 | Substantially Equivalent |