Fortoss Vital Bone Graft Substitute
FDA 510(k) K050170 · Biocomposites, Ltd.
510(k) numberK050170
Submission
- Device name
- Fortoss Vital Bone Graft Substitute
- Applicant
- Biocomposites, Ltd.
Keele, GB - Received
- January 26, 2005
- Decision date
- August 26, 2005
- 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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| K082381 | GenexMQV · Traditional | 11/14/2008SE |
| K082383 | Fortoss VitalLYC · Special | 09/05/2008SE |
| K073341 | Genex PuttyMQV · Traditional | 07/09/2008SE |
| K081428 | Modification to Doubleplay Suture AnchorHWC · Special | 06/20/2008SE |
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Questions and answers
When was Fortoss Vital Bone Graft Substitute cleared by the FDA?
Fortoss Vital Bone Graft Substitute (K050170) received a 510(k) decision of Substantially Equivalent on August 26, 2005, 212 days after the submission was received.
What is the product code of K050170?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.