FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tranquil Interbody System
K Number: K170297
·
Decision Jun 27, 2017
Classifications
1
FEI Numbers
422
Registration Numbers
422
Same Product Code
869
Applicant Total
16
Review Days
147
Basic Information
- Device Name
- Tranquil Interbody System
- K Number
- K170297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nexus Spine, LLC
- Date Received
- January 31, 2017
- Decision Date
- June 27, 2017
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAX), ordered by most recent decision date.
PathLoc Lumbar Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams
FDA 510(k)
FDA Class 2
·Orthopedic
aprevo® posterior/transforaminal lumbar interbody fusion device
FDA 510(k)
FDA Class 2
·Orthopedic
Testa TP Pivoting Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
X-PAC® LLIF Expandable Lateral Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Sep 18, 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 |