K232889
- 510(k) number
- K232889
- Device name
- METICULY Patient-specific titanium maxillofacial mesh implant
- Applicant
- Meticuly Co., Ltd. TH
- Product code
- JEY — Plate, Bone
- Decision date
- 2024-04-30
- Date received
- 2023-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K232889.pdf
Official FDA record: K232889
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.