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FDA 510(k)

BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS

K-Number: K073102 · 2007-11-27

ApplicantBiomet Manufacturing Corp
Decision Date2007-11-27
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS 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 2007-11-27 under 510(k) number K073102. 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 BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS?

BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS is a medical device that received FDA 510(k) clearance on 2007-11-27. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K073102.

When did BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS receive FDA 510(k) clearance?

BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS received FDA 510(k) clearance on 2007-11-27, under 510(k) number K073102.

Who is the listed applicant for BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS?

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 BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS?

The FDA product code for BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS 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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