FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XENCO MEDICAL CERVICAL INTERBODY SYSTEM
K Number: K140786
·
Decision Sep 3, 2014
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
16
Review Days
156
Basic Information
- Device Name
- XENCO MEDICAL CERVICAL INTERBODY SYSTEM
- K Number
- K140786
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Xenco Medical, LLC
- Date Received
- March 31, 2014
- Decision Date
- September 3, 2014
- 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 |
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| K Number | Device Name | ||
|---|---|---|---|
| K243673 | Xenco Medical CancelleX Cervical Interbody System | Jan 29, 2025 | Substantially Equivalent |
| 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 |