FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OsteoFlo HydroFiber
K Number: K243949
·
Decision May 28, 2025
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
25
Review Days
156
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Basic Information
- Device Name
- OsteoFlo HydroFiber
- K Number
- K243949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SurGenTec, LLC
- Date Received
- December 23, 2024
- Decision Date
- May 28, 2025
- Product Code
- MQV
- 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 |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | FDA class 2 | Orthopedic |
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