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FDA 510(k)

TRI-POLAR SYSTEM

K-Number: K991990 · 1999-09-10

ApplicantBiomet, Inc.
Decision Date1999-09-10
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRI-POLAR 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 1999-09-10 under 510(k) number K991990. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-POLAR SYSTEM?

TRI-POLAR SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-10. The listed applicant is Biomet, Inc.. The 510(k) number is K991990.

When did TRI-POLAR SYSTEM receive FDA 510(k) clearance?

TRI-POLAR SYSTEM received FDA 510(k) clearance on 1999-09-10, under 510(k) number K991990.

Who is the listed applicant for TRI-POLAR 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 TRI-POLAR SYSTEM?

The FDA product code for TRI-POLAR SYSTEM is KWY.

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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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