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FDA 510(k)

MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM

K-Number: K990197 · 1999-02-04

ApplicantExactech, Inc.
Decision Date1999-02-04
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 1999-02-04 under 510(k) number K990197. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM?

MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1999-02-04. The listed applicant is Exactech, Inc.. The 510(k) number is K990197.

When did MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM receive FDA 510(k) clearance?

MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM received FDA 510(k) clearance on 1999-02-04, under 510(k) number K990197.

Who is the listed applicant for MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM?

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

What is the FDA product code for MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM?

The FDA product code for MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM is MEH.

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Related Devices (Code: MEH)

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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