Prime BIOFOAM® Multi-Hole Shells
K-Number: K201157 · 2021-08-24
ApplicantMicroport Orthopedics, Inc.
Decision Date2021-08-24
Product CodeMBL
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Prime BIOFOAM® Multi-Hole Shells is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2021-08-24 under approval number K201157. The device is classified under product code MBL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Prime BIOFOAM® Multi-Hole Shells?
Prime BIOFOAM® Multi-Hole Shells is a medical device that received FDA 510(k) clearance on 2021-08-24. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K201157.
When was Prime BIOFOAM® Multi-Hole Shells approved by the FDA?
Prime BIOFOAM® Multi-Hole Shells received FDA 510(k) clearance on 2021-08-24, under approval number K201157.
What company makes Prime BIOFOAM® Multi-Hole Shells?
Prime BIOFOAM® Multi-Hole Shells is manufactured by Microport Orthopedics, Inc..
What is the FDA product code for Prime BIOFOAM® Multi-Hole Shells?
The FDA product code for Prime BIOFOAM® Multi-Hole Shells is MBL.
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K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
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Related Devices (Code: MBL)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.