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FDA 510(k)

100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES

K-Number: K070399 · 2007-05-04

ApplicantBiomet Manufacturing, Inc.
Decision Date2007-05-04
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2007-05-04 under 510(k) number K070399. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES?

100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES is a medical device that received FDA 510(k) clearance on 2007-05-04. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K070399.

When did 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES receive FDA 510(k) clearance?

100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES received FDA 510(k) clearance on 2007-05-04, under 510(k) number K070399.

Who is the listed applicant for 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES?

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

What is the FDA product code for 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES?

The FDA product code for 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES is JDI.

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Related Devices (Code: JDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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