Bonebridge Osteosynthesis Plating System
Summary
Bonebridge AG received 510(k) clearance for Bonebridge Osteosynthesis Plating System, a HRS device. Cleared on 2024-10-31.
Details
Source
510(k) Clearance
External ID
K242399
Action Date
2024-10-31
Status
Traditional
Category
device
Product Code
HRS
Product Description
Bonebridge Osteosynthesis Plating System. Product code: HRS.
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. Bonebridge AG has received 9 total clearances in our database.
Bonebridge AG has 9 FDA actions in our database, including 9 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 Bonebridge AG have FDA actions?
Bonebridge AG has 9 FDA actions in our database, including 0 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K242399" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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