FDA 510(k)

MULTIFIT TOTAL HIP SYSTEM

K-Number: K101472 · 2011-01-05

Decision Date2011-01-05

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MULTIFIT TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Otis Biotech Co., Ltd.. It received FDA 510(k) clearance on 2011-01-05 under 510(k) number K101472. 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 MULTIFIT TOTAL HIP SYSTEM?

MULTIFIT TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2011-01-05. The listed applicant is Otis Biotech Co., Ltd.. The 510(k) number is K101472.

When did MULTIFIT TOTAL HIP SYSTEM receive FDA 510(k) clearance?

MULTIFIT TOTAL HIP SYSTEM received FDA 510(k) clearance on 2011-01-05, under 510(k) number K101472.

Who is the listed applicant for MULTIFIT TOTAL HIP SYSTEM?

The FDA 510(k) record lists Otis Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIFIT TOTAL HIP SYSTEM?

The FDA product code for MULTIFIT TOTAL HIP SYSTEM is LZO.

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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.