OrthoFit Aligner (OrthoFit Aligner A2)
Summary
Spident Co., Ltd. received 510(k) clearance for OrthoFit Aligner (OrthoFit Aligner A2), a DYH device. Cleared on 2026-10-13.
Details
Source
510(k) Clearance
External ID
K262433
Action Date
2026-10-13
Status
Traditional
Category
device
Product Code
DYH
Product Description
OrthoFit Aligner (OrthoFit Aligner A2). Product code: DYH.
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 480 device clearances issued this month. Spident Co., Ltd. has received 11 total clearances in our database.
Spident Co., Ltd. has 11 FDA actions in our database, including 11 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 Spident Co., Ltd. have FDA actions?
Spident Co., Ltd. has 11 FDA actions in our database, including 0 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K262433" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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