Exactech® Equinoxe® Laser Cage Glenoid
Summary
Exactech, Inc. received 510(k) clearance for Exactech® Equinoxe® Laser Cage Glenoid, a KWS device. Cleared on 2022-03-04.
Details
Source
510(k) Clearance
External ID
K212356
Action Date
2022-03-04
Status
Traditional
Category
device
Product Code
KWS
Product Description
Exactech® Equinoxe® Laser Cage Glenoid. Product code: KWS.
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. Exactech, Inc. has received 13 total clearances in our database.
Exactech, Inc. has 110 FDA actions in our database, including 97 recalls and 13 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 Exactech, Inc. have FDA actions?
Exactech, Inc. has 110 FDA actions in our database, including 97 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K212356" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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