Xylos Porous Surgical Mesh
FDA 510(k) K090880 · Xylos Corporation
510(k) numberK090880
Submission
- Device name
- Xylos Porous Surgical Mesh
- Applicant
- Xylos Corporation
Langhorne, PA, US - Received
- March 31, 2009
- Decision date
- May 27, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K111584 | Xylos Macro-Porous Surgical MeshFTM · Traditional | 08/25/2011SE |
| K100984 | Xylos Vessel GuardOMR · Traditional | 07/07/2010SESU |
| K090778 | Mta Protective SheetFTM · Traditional | 04/28/2009SE |
| K083823 | Securian Tissue Reinforcement MatrixFTM · Traditional | 03/18/2009SE |
| K081882 | Modification to Xylos Surgical MeshFTM · Special | 07/11/2008SE |
| K023237 | Xylos Surgical MeshFTM · Traditional | 03/18/2003SE |
| K024054 | Xylos Xcell Antimicrobial DressingMGQ · Traditional | 03/07/2003SE |
| K974251 | X-Cell Wound DressingMGQ · Traditional | 06/22/1998SE |
Questions and answers
When was Xylos Porous Surgical Mesh cleared by the FDA?
Xylos Porous Surgical Mesh (K090880) received a 510(k) decision of Substantially Equivalent on May 27, 2009, 57 days after the submission was received.
What is the product code of K090880?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.