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510(k) K083039

VERITAS COLLAGEN MATRIX (DRY) by Synovis Surgical Innovations — Product Code FTM

K083039 is an FDA 510(k) premarket notification submitted by Synovis Surgical Innovations for the device "VERITAS COLLAGEN MATRIX (DRY)". The FDA issued a decision of Substantially Equivalent on November 26, 2008. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Synovis Surgical Innovations has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2008
Date Received
October 14, 2008
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 Synovis Surgical Innovations

  • K122306 — SYNOVIS COLLAGEN MATRIX (TBD) (March 8, 2013)
  • K062915 — VERITAS COLLAGEN MATRIX (December 6, 2006)
  • K041669 — VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD (October 27, 2004)
  • K040415 — PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PE (April 14, 2004)
  • K040119 — PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE L (March 17, 2004)
  • K040001 — STEERABLE STYLET (March 9, 2004)
  • K030879 — VERITAS COLLAGEN MATRIX (April 24, 2003)

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