SuturePatch Tissue Reinforcement— 510(k) K243480

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K243480 for SuturePatch Tissue Reinforcement, Substantially Equivalent on 2025-05-29. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant
Arthrex, Inc.
Product code
Code OWX
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Naples, FL, US
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