FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System
K Number: K171439
·
Decision Jul 20, 2017
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
96
Review Days
65
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
- EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System
- K Number
- K171439
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medos International SARL
- Date Received
- May 16, 2017
- Decision Date
- July 20, 2017
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWQ), ordered by most recent decision date.
ARIES Anterior Cervical Plate Systems
FDA 510(k)
FDA Class 2
·Orthopedic
CastleLoc-P Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
corra cervical plating system
FDA 510(k)
FDA Class 2
·Orthopedic
VyPlate Anterior Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ANTERIS Thoracolumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
PathLoc Lumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Medos International SARL
| K Number | Device Name | ||
|---|---|---|---|
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | May 26, 2026 | Substantially Equivalent |
| K260240 | SYMPHONY Navigation Ready Instruments | Mar 27, 2026 | Substantially Equivalent |
| K253249 | TriALTIS Spine System | Oct 21, 2025 | Substantially Equivalent |
| K243249 | TriALTIS Spine System | Jan 17, 2025 | Substantially Equivalent |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays | Sep 16, 2024 | Substantially Equivalent |
| K242042 | TriALTIS Spine System | Sep 9, 2024 | Substantially Equivalent |
| K233684 | TriALTIS Spine System | Dec 12, 2023 | Substantially Equivalent |
| K233366 | SYMPHONY OCT System | Nov 9, 2023 | Substantially Equivalent |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor | Oct 6, 2023 | Substantially Equivalent |
| K231479 | TriALTIS Spine System | Sep 22, 2023 | Substantially Equivalent |