FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPINEOLOGY SPINOUS PROCESS PLATE
K Number: K123232
·
Decision Feb 7, 2013
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
54
Review Days
114
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Basic Information
- Device Name
- SPINEOLOGY SPINOUS PROCESS PLATE
- K Number
- K123232
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spineology, Inc.
- Date Received
- October 16, 2012
- Decision Date
- February 7, 2013
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System | Oct 18, 2023 | Substantially Equivalent |
| K213876 | Spineology Navigation Instruments | Aug 5, 2022 | Substantially Equivalent |
| K210155 | Duo Expandable Interbody Fusion System | Feb 19, 2021 | Substantially Equivalent |
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| K192047 | Rampart One Lumbar Interbody Fusion System | Aug 23, 2019 | Substantially Equivalent |
| K191091 | Rampart One Lumbar Interbody Fusion System | May 23, 2019 | Substantially Equivalent |
| K190055 | Duo Lumbar Interbody Fusion Device | Mar 7, 2019 | Substantially Equivalent |