FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SPINEOLOGY FACET SCREW
K Number: K092464
·
Decision Nov 9, 2009
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
77
Applicant Total
54
Review Days
90
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Basic Information
- Device Name
- SPINEOLOGY FACET SCREW
- K Number
- K092464
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spineology, Inc.
- Date Received
- August 11, 2009
- Decision Date
- November 9, 2009
- Product Code
- MRW
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | FDA unclassified | Unknown |
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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 |
| DEN200010 | Spineology Interbody Fusion System | Sep 18, 2020 | Unknown |
| 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 |