FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAXX IBL SYSTEM
K Number: K131071
·
Decision Aug 20, 2013
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
59
Review Days
125
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STAXX IBL SYSTEM
- K Number
- K131071
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spine Wave, Inc.
- Date Received
- April 17, 2013
- Decision Date
- August 20, 2013
- 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.
Fule Interbody Fusion Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Exceed® Biplanar Expandable Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
BMD Titanium Spinal Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Ventana® P/T Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
VersaLift Expandable System
FDA 510(k)
FDA Class 2
·Orthopedic
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Spine Wave, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260286 | Dynamo Spinal Cement; Salvo® Spine System | Jun 15, 2026 | Substantially Equivalent |
| K261159 | Exceed® Biplanar Expandable Interbody System | May 29, 2026 | Substantially Equivalent |
| K243816 | Testa TP Pivoting Spacer System | Jun 27, 2025 | Substantially Equivalent |
| K251131 | Annex® 2 Adjacent Level System | Jun 6, 2025 | Substantially Equivalent |
| K243514 | Salvo® Robotic Navigation Instruments | Apr 3, 2025 | Substantially Equivalent |
| K240685 | Salvo® Spine System | May 6, 2024 | Substantially Equivalent |
| K231275 | Exceed Biplanar Expandable Interbody System | Jul 25, 2023 | Substantially Equivalent |
| K222362 | Salvo® Spine System | Aug 29, 2022 | Substantially Equivalent |
| K202476 | Salvo® Spine System | Nov 5, 2020 | Substantially Equivalent |
| K192526 | Spine Wave Navigated Instruments | Oct 10, 2019 | Substantially Equivalent |