Prime BIOFOAM® Multi-Hole Shells
Summary
Microport Orthopedics, Inc. received 510(k) clearance for Prime BIOFOAM® Multi-Hole Shells, a MBL device. Cleared on 2021-08-24.
Details
Source
510(k) Clearance
External ID
K201157
Action Date
2021-08-24
Status
Traditional
Category
device
Product Code
MBL
Product Description
Prime BIOFOAM® Multi-Hole Shells. Product code: MBL.
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. Microport Orthopedics, Inc. has received 11 total clearances in our database.
Microport Orthopedics, Inc. has 17 FDA actions in our database, including 6 recalls and 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 Microport Orthopedics, Inc. have FDA actions?
Microport Orthopedics, Inc. has 17 FDA actions in our database, including 6 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K201157" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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