510(k) K243949
- Device
- OsteoFlo HydroFiber
- Applicant
- SurGenTec, LLC
- 510(k) number
- K243949
- Product code
- MQV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-28
- Date received
- 2024-12-23
- Regulation
- 888.3045
- Classification name
- Filler, Bone Void, Calcium Compound
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Guilherme Pires
- Address
- 911 Clint Moore Rd. Boca Raton FL US 33487 33487
FDA Registration Numbers
- 1423662
- 1450662
- 3006788678
- 3043620406
- 3005180920
- 3013820501
- 1645368
- 1416980
- 3006404071
- 3013176080
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Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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