Vy Spine VySpan PCT System
Summary
Vy Spine, LLC received 510(k) clearance for Vy Spine VySpan PCT System, a NKG device. Cleared on 2021-12-10.
Details
Source
510(k) Clearance
External ID
K213394
Action Date
2021-12-10
Status
Traditional
Category
device
Product Code
NKG
Product Description
Vy Spine VySpan PCT System. Product code: NKG.
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. Vy Spine, LLC has received 21 total clearances in our database.
Vy Spine, LLC has 21 FDA actions in our database, including 21 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 Vy Spine, LLC have FDA actions?
Vy Spine, LLC has 21 FDA actions in our database, including 0 recalls and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213394" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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