FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNAMIS Implant System
K Number: K251075
·
Decision Apr 25, 2025
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
130
Applicant Total
3
Review Days
17
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DYNAMIS Implant System
- K Number
- K251075
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Promethean Restorative, LLC
- Date Received
- April 8, 2025
- Decision Date
- April 25, 2025
- Product Code
- OUR
- 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 |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OUR), ordered by most recent decision date.
CATAMARAN SI Joint Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
iFuse INTRA Ti Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Falco Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Sacroiliac Joint Truss System (SJTS)
FDA 510(k)
FDA Class 2
·Orthopedic
OptumSI Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
SIros-X System
FDA 510(k)
FDA Class 2
·Orthopedic