FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALTA Anterior Cervical Corpectomy System
K Number: K190426
·
Decision Oct 24, 2019
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
17
Applicant Total
8
Review Days
244
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
- ALTA Anterior Cervical Corpectomy System
- K Number
- K190426
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Astura Medical, LLC
- Date Received
- February 22, 2019
- Decision Date
- October 24, 2019
- Product Code
- PLR
- 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 |
|---|---|---|---|
| PLR | Spinal Vertebral Body Replacement Device - Cervical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PLR), ordered by most recent decision date.
Atlas Spine HiRISE Expandable Cervical Corpectomy System
FDA 510(k)
FDA Class 2
·Orthopedic
RIGEL 3DR Anterior Cervical Corpectomy System
FDA 510(k)
FDA Class 2
·Orthopedic
Galileo Vertebral Body Replacement Device
FDA 510(k)
FDA Class 2
·Orthopedic
MediExpand Cervical Expandable VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
CAPRI Corpectomy Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
Galileo Vertebral Body Replacement Device
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Astura Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K202495 | SIRION Lateral Lumbar Interbody Fusion | Jan 6, 2021 | Substantially Equivalent |
| K202065 | DOLOMITE Anterior Cervical Stabilization System | Oct 26, 2020 | Substantially Equivalent |
| K192492 | EL CAPITAN Anterior Lumber Interbody System | Apr 21, 2020 | Substantially Equivalent |
| K192006 | SIRION Lateral Lumbar Interbody System | Apr 2, 2020 | Substantially Equivalent |
| K182877 | HALF DOME Posterior Lumbar Interbody System | May 3, 2019 | Substantially Equivalent |
| K182239 | OLYMPIC Posterior Spinal Fixation System | Oct 18, 2018 | Substantially Equivalent |
| K181139 | OLYMPIC Posterior Spinal Fixation System | Jul 6, 2018 | Substantially Equivalent |