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FDA 510(k)

ACUFIT TOTAL HIP

K-Number: K904383 · 1990-12-20

ApplicantAcu Med, Inc.
Decision Date1990-12-20
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFIT TOTAL HIP is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1990-12-20 under 510(k) number K904383. 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 ACUFIT TOTAL HIP?

ACUFIT TOTAL HIP is a medical device that received FDA 510(k) clearance on 1990-12-20. The listed applicant is Acu Med, Inc.. The 510(k) number is K904383.

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

ACUFIT TOTAL HIP received FDA 510(k) clearance on 1990-12-20, under 510(k) number K904383.

Who is the listed applicant for ACUFIT TOTAL HIP?

The FDA 510(k) record lists Acu Med, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUFIT TOTAL HIP?

The FDA product code for ACUFIT TOTAL HIP is KWY.

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Other records listing Acu Med, Inc. as applicant

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Related Devices (Code: 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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