510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133169Substantially Equivalent

Meso Tendon Matrix

Kensey Nash Corporation dba Dsm Biomedical, Exton PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133169 is the FDA 510(k) clearance record for MESO TENDON MATRIX, a class II device, cleared for Kensey Nash Corporation Dba Dsm Biomedical on under FDA product code OWY (Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon). FDA's definition for product code OWY reads: "For reinforcement of soft tissue where weakness exists in tendon repair". FDA records list 7 510(k) clearances for Kensey Nash Corporation Dba Dsm Biomedical, from to . As of , FDA records show no recalls naming K133169.

Clearance record

Decision date
Received
(64 days to decision)
Product code
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kensey Nash Corporation Dba Dsm Biomedical 735 Pennsylvania Dr., Exton PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OWY

Trailing 12 months

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

FDA records show no clearances under product code OWY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OWY, 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