SMART Taylor Spatial Frame
Summary
Smith & Nephew, Inc. received 510(k) clearance for SMART Taylor Spatial Frame, a KTT device. Cleared on 2021-07-29.
Details
Source
510(k) Clearance
External ID
K210953
Action Date
2021-07-29
Status
Traditional
Category
device
Product Code
KTT
Product Description
SMART Taylor Spatial Frame. Product code: KTT.
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 389 device clearances issued this month. Smith & Nephew, Inc. has received 48 total clearances in our database.
Smith & Nephew, Inc. has 82 FDA actions in our database, including 34 recalls and 48 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 Smith & Nephew, Inc. have FDA actions?
Smith & Nephew, Inc. has 82 FDA actions in our database, including 34 recalls and 48 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K210953" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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