FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOJAVE Expandable Interbody System
K Number: K193203
·
Decision Feb 18, 2020
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
100
Review Days
90
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
- MOJAVE Expandable Interbody System
- K Number
- K193203
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2m, Inc.
- Date Received
- November 20, 2019
- Decision Date
- February 18, 2020
- 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 K2m, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260546 | Q Pedicle Instruments | Mar 17, 2026 | Substantially Equivalent |
| K253545 | Vulcan Spinal System | Feb 10, 2026 | Substantially Equivalent |
| K252873 | Q Interbody Instruments | Feb 6, 2026 | Substantially Equivalent |
| K211320 | CAPRI Corpectomy Cage System | Feb 24, 2022 | Substantially Equivalent |
| K202528 | Cannulated Power Driver Attachment | Oct 26, 2020 | Substantially Equivalent |
| K201006 | K2M Navigation Instruments | Aug 7, 2020 | Substantially Equivalent |
| K193129 | Yukon OCT Spinal System | Feb 7, 2020 | Substantially Equivalent |
| K192911 | Brainlab Compatible K2M Navigation Instruments | Nov 14, 2019 | Substantially Equivalent |
| K190179 | SAHARA Stabilization System | Oct 3, 2019 | Substantially Equivalent |
| K190584 | CAYMAN LP Plate System | May 15, 2019 | Substantially Equivalent |