K242631
- 510(k) number
- K242631
- Device name
- REGENETEN Bioinductive Implant
- Applicant
- Smith & Nephew Inc., Endoscopy Div. MA · US
- Product code
- OWY — Mesh, Surgical, Collagen, Orthopaedics, Reinforcemen
- Decision date
- 2024-11-26
- Date received
- 2024-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K242631.pdf
Official FDA record: K242631
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.