FDA 510(k)

DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)

K-Number: K990849 · 1999-12-20

Decision Date1999-12-20

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 1999-12-20 under 510(k) number K990849. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)?

DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) is a medical device that received FDA 510(k) clearance on 1999-12-20. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K990849.

When did DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) receive FDA 510(k) clearance?

DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) received FDA 510(k) clearance on 1999-12-20, under 510(k) number K990849.

Who is the listed applicant for DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)?

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

What is the FDA product code for DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)?

The FDA product code for DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) is LPH.

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Related Devices (Code: LPH)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.