510(k) K232889
K232889 is an FDA 510(k) premarket notification submitted by Meticuly Co., Ltd. for the device "METICULY Patient-specific titanium maxillofacial mesh implant". The FDA issued a decision of Substantially Equivalent on April 30, 2024. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Meticuly Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2024
- Date Received
- September 18, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type