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510(k) K090778

MTA PROTECTIVE SHEET by Xylos Corporation — Product Code FTM

K090778 is an FDA 510(k) premarket notification submitted by Xylos Corporation for the device "MTA PROTECTIVE SHEET". The FDA issued a decision of Substantially Equivalent on April 28, 2009. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Xylos Corporation has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2009
Date Received
March 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Xylos Corporation

  • K111584 — XYLOS MACRO-POROUS SURGICAL MESH (August 25, 2011)
  • K100984 — XYLOS VESSEL GUARD (July 7, 2010)
  • K090880 — XYLOS POROUS SURGICAL MESH (May 27, 2009)
  • K083823 — SECURIAN TISSUE REINFORCEMENT MATRIX (March 18, 2009)
  • K081882 — MODIFICATION TO XYLOS SURGICAL MESH (July 11, 2008)
  • K023237 — XYLOS SURGICAL MESH (March 18, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (March 7, 2003)
  • K974251 — X-CELL WOUND DRESSING (June 22, 1998)

Other clearances for product code FTM

  • K250598 — Endoform Reconstructive Template - PLGA (June 3, 2025)
  • K243595 — OviTex PRS (Long-Term Resorbable) (December 19, 2024)
  • K233991 — CanGaroo RM Antibacterial Envelope (June 14, 2024)
  • K241126 — OviTex PRS (May 22, 2024)
  • K223052 — Peri-Guard and Supple Peri-Guard (April 7, 2023)
  • K214070 — OviTex PRS (Long Term Resorbable) (March 21, 2023)
  • K213163 — VersaWrap (October 29, 2021)
  • K213125 — PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECU (October 27, 2021)
  • K203496 — Nexo-Gide Bilayer Collagen Membrane (July 14, 2021)
  • K203600 — VersaWrap (March 9, 2021)

FDA data resources