FDA 510(k)

TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT

K-Number: K090897 · 2009-10-23

Decision Date2009-10-23

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT 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 2009-10-23 under 510(k) number K090897. 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 TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT?

TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT is a medical device that received FDA 510(k) clearance on 2009-10-23. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K090897.

When did TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT receive FDA 510(k) clearance?

TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT received FDA 510(k) clearance on 2009-10-23, under 510(k) number K090897.

Who is the listed applicant for TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT?

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 TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT?

The FDA product code for TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT is 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.