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FDA 510(k)

BIOMET BI-POLAR SHOULDER SYSTEM

K-Number: K002998 · 2000-10-06

ApplicantBiomet, Inc.
Decision Date2000-10-06
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET BI-POLAR SHOULDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2000-10-06 under 510(k) number K002998. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMET BI-POLAR SHOULDER SYSTEM?

BIOMET BI-POLAR SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2000-10-06. The listed applicant is Biomet, Inc.. The 510(k) number is K002998.

When did BIOMET BI-POLAR SHOULDER SYSTEM receive FDA 510(k) clearance?

BIOMET BI-POLAR SHOULDER SYSTEM received FDA 510(k) clearance on 2000-10-06, under 510(k) number K002998.

Who is the listed applicant for BIOMET BI-POLAR SHOULDER SYSTEM?

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

What is the FDA product code for BIOMET BI-POLAR SHOULDER SYSTEM?

The FDA product code for BIOMET BI-POLAR SHOULDER SYSTEM is KWT.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: KWT)

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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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