METICULY Patient-specific titanium maxillofacial mesh implant
Summary
Meticuly Co., Ltd. received 510(k) clearance for METICULY Patient-specific titanium maxillofacial mesh implant, a JEY device. Cleared on 2024-04-30.
Details
Source
510(k) Clearance
External ID
K232889
Action Date
2024-04-30
Status
Traditional
Category
device
Product Code
JEY
Product Description
METICULY Patient-specific titanium maxillofacial mesh implant. Product code: JEY.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Meticuly Co., Ltd. has received 3 total clearances in our database.
Meticuly Co., Ltd. has 3 FDA actions in our database, including 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Meticuly Co., Ltd. have FDA actions?
Meticuly Co., Ltd. has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232889" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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