Healos FX Bone Graft Substitute and Graft Mixing and Delivery System
FDA 510(k) K062495 · Depuy Spine, Inc.
510(k) numberK062495
Submission
- Device name
- Healos FX Bone Graft Substitute and Graft Mixing and Delivery System
- Applicant
- Depuy Spine, Inc.
Raynham, MA, US - Received
- August 25, 2006
- Decision date
- October 13, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
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| K260364 | Device 300419 StripMQV · Traditional | Geistlich Pharma AG | 06/02/2026SE |
| K252797 | JAZBI Resorbable Bone Void FillerMQV · Traditional | Sdip Innovations Pty, Ltd. | 05/26/2026SE |
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| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
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| K251720 | OsteoFlo HydroFiberMQV · Special | SurGenTec, LLC | 07/02/2025SE |
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| K110216 | Expedium System, Viper SystemNKB · Special | 04/01/2011SE |
| K103133 | Veper System, Expedium SystemNKB · Special | 01/18/2011SE |
| K101993 | Viper System, Expedium SystemNKB · Special | 12/07/2010SE |
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Questions and answers
When was Healos FX Bone Graft Substitute and Graft Mixing and Delivery System cleared by the FDA?
Healos FX Bone Graft Substitute and Graft Mixing and Delivery System (K062495) received a 510(k) decision of Substantially Equivalent on October 13, 2006, 49 days after the submission was received.
What is the product code of K062495?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.