FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇭 Thailand
METICULY Patient-specific titanium maxillofacial mesh implant
K Number: K232889
·
Decision Apr 30, 2024
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
3
Review Days
225
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Basic Information
- Device Name
- METICULY Patient-specific titanium maxillofacial mesh implant
- K Number
- K232889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meticuly Co., Ltd.
- Date Received
- September 18, 2023
- Decision Date
- April 30, 2024
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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