Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft Substitute
FDA 510(k) K090850 · Apatech , Ltd.
510(k) numberK090850
Submission
- Device name
- Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft Substitute
- Applicant
- Apatech , Ltd.
Oregon City, OR, US - Received
- March 30, 2009
- Decision date
- July 30, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYC – Bone Grafting Material, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
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More from Institut Straumann AG
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K082073 | Actifuse Flow Bone Graft SubstituteMQV · Traditional | 09/11/2008SE |
| 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 Bone Graft Substitute, Actifuse Microgranules Bone Graft Substitute cleared by the FDA?
Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft Substitute (K090850) received a 510(k) decision of Substantially Equivalent on July 30, 2009, 122 days after the submission was received.
What is the product code of K090850?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.