WaveForm L System, WaveForm TO System, WaveForm TA System
Summary
SeaSpine Orthopedics Corporation received 510(k) clearance for WaveForm L System, WaveForm TO System, WaveForm TA System, a MAX device. Cleared on 2022-05-04.
Details
Source
510(k) Clearance
External ID
K213420
Action Date
2022-05-04
Status
Traditional
Category
device
Product Code
MAX
Product Description
WaveForm L System, WaveForm TO System, WaveForm TA System. Product code: MAX.
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. SeaSpine Orthopedics Corporation has received 21 total clearances in our database.
SeaSpine Orthopedics Corporation has 30 FDA actions in our database, including 9 recalls and 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 SeaSpine Orthopedics Corporation have FDA actions?
SeaSpine Orthopedics Corporation has 30 FDA actions in our database, including 9 recalls and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213420" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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