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FDA 510(k)

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)

K-Number: K014072 · 2002-03-08

ApplicantDisc-O-Tech Medical Technologies, Ltd.
Decision Date2002-03-08
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) is the device name listed in this FDA 510(k) record. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2002-03-08 under 510(k) number K014072. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)?

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) is a medical device that received FDA 510(k) clearance on 2002-03-08. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. The 510(k) number is K014072.

When did FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) receive FDA 510(k) clearance?

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) received FDA 510(k) clearance on 2002-03-08, under 510(k) number K014072.

Who is the listed applicant for FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)?

The FDA 510(k) record lists Disc-O-Tech Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)?

The FDA product code for FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) is KWY.

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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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