SuturePatch Tissue Reinforcement— 510(k) K243480
Substantially EquivalentArthrex, 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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