Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015
FDA 510(k) K081758 · Depuy Spine, Inc.
510(k) numberK081758
Submission
- Device name
- Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015
- Applicant
- Depuy Spine, Inc.
Raynham, MA, US - Received
- June 20, 2008
- Decision date
- September 3, 2008
- 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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|---|---|---|---|
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| 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 |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | Stryker Spine | 04/24/2026SE |
| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | Prosidyan, Inc. | 10/22/2025SE |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 10/13/2025SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | Wright Medical Technology, Inc. (Stryker… | 09/30/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | Geistlich Pharma AG | 07/17/2025SE |
| 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 Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015 cleared by the FDA?
Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010, 276175015 (K081758) received a 510(k) decision of Substantially Equivalent on September 3, 2008, 75 days after the submission was received.
What is the product code of K081758?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.