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FDA 510(k)

ACUMED MODULAR SHOULDER SYSTEM

K-Number: K992525 · 2000-02-04

ApplicantAcu Med, Inc.
Decision Date2000-02-04
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUMED MODULAR SHOULDER SYSTEM 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 2000-02-04 under 510(k) number K992525. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUMED MODULAR SHOULDER SYSTEM?

ACUMED MODULAR SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2000-02-04. The listed applicant is Acu Med, Inc.. The 510(k) number is K992525.

When did ACUMED MODULAR SHOULDER SYSTEM receive FDA 510(k) clearance?

ACUMED MODULAR SHOULDER SYSTEM received FDA 510(k) clearance on 2000-02-04, under 510(k) number K992525.

Who is the listed applicant for ACUMED MODULAR SHOULDER SYSTEM?

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 ACUMED MODULAR SHOULDER SYSTEM?

The FDA product code for ACUMED MODULAR SHOULDER SYSTEM is HSD.

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Other records listing Acu Med, Inc. as applicant

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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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