Treace Medical Systems (TMC) Plating System
Summary
Treace Medical Concepts, Inc. received 510(k) clearance for Treace Medical Systems (TMC) Plating System, a HRS device. Cleared on 2024-02-22.
Details
Source
510(k) Clearance
External ID
K240173
Action Date
2024-02-22
Status
Special
Category
device
Product Code
HRS
Product Description
Treace Medical Systems (TMC) Plating System. Product code: HRS.
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. Treace Medical Concepts, Inc. has received 6 total clearances in our database.
Treace Medical Concepts, Inc. has 7 FDA actions in our database, including 1 recall and 6 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 Treace Medical Concepts, Inc. have FDA actions?
Treace Medical Concepts, Inc. has 7 FDA actions in our database, including 1 recall and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K240173" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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