FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Spinal Elements' Spinous Process Plate System
K Number: K160465
·
Decision Jul 28, 2016
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
47
Applicant Total
49
Review Days
160
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Basic Information
- Device Name
- Spinal Elements' Spinous Process Plate System
- K Number
- K160465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinal Elements, Inc.
- Date Received
- February 19, 2016
- Decision Date
- July 28, 2016
- Product Code
- PEK
- 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 |
|---|---|---|---|
| PEK | Spinous Process Plate | FDA class 2 | Orthopedic |
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Other Clearances by Spinal Elements, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260506 | Ventana® P/T Lumbar Interbody System | May 15, 2026 | Substantially Equivalent |
| K253559 | Ventana A Anterior Lumbar Interbody System | Feb 25, 2026 | Substantially Equivalent |
| K250773 | Luna® Ti Interbody Fusion System | Feb 4, 2026 | Substantially Equivalent |
| K242527 | The Karma® Fixation System | May 21, 2025 | Substantially Equivalent |
| K243916 | Primus Spinal Fixation System | Feb 21, 2025 | Substantially Equivalent |
| K231593 | Sapphire X3 Anterior Cervical Plate System | Aug 2, 2023 | Substantially Equivalent |
| K231252 | Ventana L Spinal System | Jun 30, 2023 | Substantially Equivalent |
| K222833 | Ventana C Spinal System | May 19, 2023 | Substantially Equivalent |
| K222516 | Mercury® II Spinal System | Dec 1, 2022 | Substantially Equivalent |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System | Jun 30, 2021 | Substantially Equivalent |