DePuy Corail AMT Hip Prosthesis
Summary
DePuy Orthopaedics, Inc. received 510(k) clearance for DePuy Corail AMT Hip Prosthesis, a LZO device. Cleared on 2022-01-06.
Details
Source
510(k) Clearance
External ID
K213839
Action Date
2022-01-06
Status
Special
Category
device
Product Code
LZO
Product Description
DePuy Corail AMT Hip Prosthesis. Product code: LZO.
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. DePuy Orthopaedics, Inc. has received 3 total clearances in our database.
DePuy Orthopaedics, Inc. has 31 FDA actions in our database, including 28 recalls and 3 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 DePuy Orthopaedics, Inc. have FDA actions?
DePuy Orthopaedics, Inc. has 31 FDA actions in our database, including 28 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213839" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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