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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2021-08-24 under 510(k) 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. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K201157.

When did Prime BIOFOAM® Multi-Hole Shells receive FDA 510(k) clearance?

Prime BIOFOAM® Multi-Hole Shells received FDA 510(k) clearance on 2021-08-24, under 510(k) number K201157.

Who is the listed applicant for Prime BIOFOAM® Multi-Hole Shells?

The FDA 510(k) record lists Microport Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prime BIOFOAM® Multi-Hole Shells?

The FDA product code for Prime BIOFOAM® Multi-Hole Shells is MBL.

Other records listing Microport Orthopedics, Inc. as applicant

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Related Devices (Code: MBL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.K182535R3 Anteverted LinersSmith & Nephew, Inc.K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.

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.

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