FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Genesys Spine Binary Lumbar Plate System
K Number: K173885
·
Decision Apr 3, 2018
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
31
Review Days
103
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Basic Information
- Device Name
- Genesys Spine Binary Lumbar Plate System
- K Number
- K173885
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genesys Spine
- Date Received
- December 21, 2017
- Decision Date
- April 3, 2018
- 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 |
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Other Clearances by Genesys Spine
| K Number | Device Name | ||
|---|---|---|---|
| K252322 | SIros-X System | Oct 22, 2025 | Substantially Equivalent |
| 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 |