FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
The Karma® Fixation System
K Number: K242527
·
Decision May 21, 2025
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
77
Applicant Total
49
Review Days
268
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Basic Information
- Device Name
- The Karma® Fixation System
- K Number
- K242527
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spinal Elements, Inc.
- Date Received
- August 26, 2024
- Decision Date
- May 21, 2025
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRW), ordered by most recent decision date.
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FFX Facet Fixation System
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CORUS-LX Implant
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FDA Unclassified
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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 |
| 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 |
| K203254 | Lucent 3D Spinal System | Mar 26, 2021 | Substantially Equivalent |