510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030879Substantially Equivalent

Veritas Collagen Matrix

SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.), St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030879 is the FDA 510(k) clearance record for VERITAS COLLAGEN MATRIX, a class II device, cleared for Synovis Surgical Innovations on under FDA product code OXE (Mesh, Surgical, Collagen, Staple Line Reinforcement). FDA's definition for product code OXE reads: "For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures". FDA records list 8 510(k) clearances for SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.), from to . As of , FDA records show no recalls naming K030879.

Clearance record

Decision date
Received
(35 days to decision)
Product code
OXE Mesh, Surgical, Collagen, Staple Line Reinforcement
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Synovis Surgical Innovations 2575 University Ave., St. Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OXE

Trailing 12 months

FDA records hold no clearances under product code OXE in the trailing twelve months.

FDA records show no clearances under product code OXE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OXE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260