FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Xenco Medical CancelleX Cervical Interbody System
K Number: K243673
·
Decision Jan 29, 2025
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
16
Review Days
63
Basic Information
- Device Name
- Xenco Medical CancelleX Cervical Interbody System
- K Number
- K243673
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xenco Medical, LLC
- Date Received
- November 27, 2024
- Decision Date
- January 29, 2025
- Product Code
- ODP
- 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 |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ODP), ordered by most recent decision date.
BluEX Cervical Expandable Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
OSTEOMNI SPINAL CAGES SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ORIO-3D Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
MOD-C
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Xenco Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K223059 | Xenco Medical InterAlign Cervical Interbody System | Jun 7, 2023 | Substantially Equivalent |
| K213456 | Xenco Medical Multilevel CerviKit | Dec 21, 2021 | Substantially Equivalent |
| K191074 | Sorrento Bone Graft Substitute | Sep 27, 2019 | Substantially Equivalent |
| K190364 | CancelleX Porous Titanium Lumbar Interbody Device | Apr 18, 2019 | Substantially Equivalent |
| K173933 | Sorrento Bioglass Bone Graft Substitute | Sep 13, 2018 | Substantially Equivalent |
| K180373 | CancelleX Porous Titanium Lumbar Interbody Device | Aug 24, 2018 | Substantially Equivalent |
| K170611 | SETx Pedicle Screw System | May 25, 2017 | Substantially Equivalent |
| K160313 | Xenco Medical Cervical Interbody System | Oct 21, 2016 | Substantially Equivalent |
| K161478 | Xenco Medical Posterior Cervical System | Sep 6, 2016 | Substantially Equivalent |
| K160986 | Xenco Medical Pedicle Screw System | May 4, 2016 | Substantially Equivalent |