FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DeGen Medical Patient Specific Implant (PSI) System
K Number: K250667
·
Decision Apr 4, 2025
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
16
Review Days
30
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Basic Information
- Device Name
- DeGen Medical Patient Specific Implant (PSI) System
- K Number
- K250667
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Degen Medical
- Date Received
- March 5, 2025
- Decision Date
- April 4, 2025
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Degen Medical
| K Number | Device Name | ||
|---|---|---|---|
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Dec 8, 2025 | Substantially Equivalent |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion System | Oct 10, 2025 | Substantially Equivalent |
| K241077 | DeGen Medical Patient Specific Implant (PSI) System | Oct 29, 2024 | Substantially Equivalent |
| K231199 | Solar Lumbar Interbody Fusion System | Jun 16, 2023 | Substantially Equivalent |
| K223418 | DeGen Impulse AM System | Mar 17, 2023 | Substantially Equivalent |
| K213918 | DeGen Navigated Instrumentation | Feb 9, 2022 | Substantially Equivalent |
| K213901 | Cyclops Anterior Cervical Plate System | Jan 7, 2022 | Substantially Equivalent |
| K210090 | Impulse AM Interbody Fusion System | Aug 30, 2021 | Substantially Equivalent |
| K203816 | DeGen Navigated Instrumentation | Apr 2, 2021 | Substantially Equivalent |
| K201287 | Impulse Interbody Fusion System | Dec 22, 2020 | Substantially Equivalent |