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FDA 510(k)

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)

K-Number: K030972 · 2003-05-30

ApplicantDisc-O-Tech Medical Technologies, Ltd.
Decision Date2003-05-30
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) 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 2003-05-30 under 510(k) number K030972. The device is classified under product code KWL. 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 MH)?

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) is a medical device that received FDA 510(k) clearance on 2003-05-30. The listed applicant is Disc-O-Tech Medical Technologies, Ltd.. The 510(k) number is K030972.

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

FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) received FDA 510(k) clearance on 2003-05-30, under 510(k) number K030972.

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

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 MH)?

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

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Related Devices (Code: KWL)

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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