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FDA 510(k)

E-POLY TIBIAL BEARINGS

K-Number: K080528 · 2008-06-17

ApplicantBiomet Orthopedics, Inc.
Decision Date2008-06-17
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

E-POLY TIBIAL BEARINGS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2008-06-17 under 510(k) number K080528. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-POLY TIBIAL BEARINGS?

E-POLY TIBIAL BEARINGS is a medical device that received FDA 510(k) clearance on 2008-06-17. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K080528.

When did E-POLY TIBIAL BEARINGS receive FDA 510(k) clearance?

E-POLY TIBIAL BEARINGS received FDA 510(k) clearance on 2008-06-17, under 510(k) number K080528.

Who is the listed applicant for E-POLY TIBIAL BEARINGS?

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

What is the FDA product code for E-POLY TIBIAL BEARINGS?

The FDA product code for E-POLY TIBIAL BEARINGS is JWH.

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Related Devices (Code: JWH)

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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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