FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Genesys Spine AIS-C Cervical Anchored Interbody System
K Number: K180056
·
Decision Mar 28, 2018
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
150
Applicant Total
19
Review Days
79
Basic Information
- Device Name
- Genesys Spine AIS-C Cervical Anchored Interbody System
- K Number
- K180056
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genesys Spine
- Date Received
- January 8, 2018
- Decision Date
- March 28, 2018
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Genesys Spine
| K Number | Device Name | ||
|---|---|---|---|
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | Feb 7, 2025 | Substantially Equivalent |
| K233595 | Genesys Spine Sacroiliac Joint Fusion System with Navigation | Mar 29, 2024 | Substantially Equivalent |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody System | Dec 13, 2023 | Substantially Equivalent |
| K220096 | Genesys Spine 3DP Lumbar Interbody System | Mar 9, 2022 | Substantially Equivalent |
| K191489 | Genesys Spine 3DP Cervical Interbody System | Jan 8, 2020 | Substantially Equivalent |
| K182987 | Genesys Spine 3DP Lumbar Interbody System | Dec 12, 2019 | Substantially Equivalent |
| K192678 | Genesys Spine Binary® Lumbar Plate System | Oct 24, 2019 | Substantially Equivalent |
| K191748 | Genesys Spine Sacroiliac Joint Fusion System | Sep 26, 2019 | Substantially Equivalent |
| K192076 | Binary® Anterior Cervical Plate System | Aug 29, 2019 | Substantially Equivalent |
| K181295 | Genesys Spine AIS-C Cervical Stand-Alone System | Aug 29, 2018 | Substantially Equivalent |