Actifuse Flow Bone Graft Substitute
FDA 510(k) K082073 · Apatech , Ltd.
510(k) numberK082073
Submission
- Device name
- Actifuse Flow Bone Graft Substitute
- Applicant
- Apatech , Ltd.
Oregon City, OR, US - Received
- July 23, 2008
- Decision date
- September 11, 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
Other 510(k)s with product code MQV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from SurGenTec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K090850 | Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft SubstituteLYC · Traditional | 07/30/2009SE |
| K082575 | Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft SubstitutesMQV · Traditional | 11/25/2008SE |
| K081979 | Actifuse Bone Graft Substitute and E-Z-Fil and Shape Bone Graft SubstituteMQV · Traditional | 11/06/2008SE |
| K080736 | Actifuse Shape Bone Graft SubstituteMQV · Special | 04/16/2008SE |
| K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteMQV · Special | 05/31/2007SE |
| K040082 | Pore-Si Bone Graft SubstituteMQV · Abbreviated | 08/04/2004SE |
| K033722 | Apapore Bone Graft SubstituteMQV · Abbreviated | 05/07/2004SE |
Questions and answers
When was Actifuse Flow Bone Graft Substitute cleared by the FDA?
Actifuse Flow Bone Graft Substitute (K082073) received a 510(k) decision of Substantially Equivalent on September 11, 2008, 50 days after the submission was received.
What is the product code of K082073?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.