K241219
- 510(k) number
- K241219
- Device name
- FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
- Applicant
- ZuriMED Technologies AG CH
- Product code
- OWX — Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinfo
- Decision date
- 2024-12-11
- Date received
- 2024-05-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241219.pdf
Official FDA record: K241219
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.