BKS Revision System
Summary
Ortho Development Corp. received 510(k) clearance for BKS Revision System, a JWH device. Cleared on 2024-10-25.
Details
Source
510(k) Clearance
External ID
K242984
Action Date
2024-10-25
Status
Special
Category
device
Product Code
JWH
Product Description
BKS Revision System. Product code: JWH.
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. Ortho Development Corp. has received 5 total clearances in our database.
Ortho Development Corp. has 5 FDA actions in our database, including 5 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 Ortho Development Corp. have FDA actions?
Ortho Development Corp. has 5 FDA actions in our database, including 0 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K242984" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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