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FDA 510(k)

ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS

K-Number: K062997 · 2006-12-08

ApplicantBiomet Manufacturing Corp
Decision Date2006-12-08
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2006-12-08 under 510(k) number K062997. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS?

ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS is a medical device that received FDA 510(k) clearance on 2006-12-08. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K062997.

When did ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS receive FDA 510(k) clearance?

ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS received FDA 510(k) clearance on 2006-12-08, under 510(k) number K062997.

Who is the listed applicant for ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS?

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

What is the FDA product code for ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS?

The FDA product code for ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS is LZO.

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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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