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FDA 510(k)

DYONICS SHOULDER PORTAL SYSTEM

K-Number: K896416 · 1990-01-02

ApplicantDyonics, Inc.
Decision Date1990-01-02
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DYONICS SHOULDER PORTAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dyonics, Inc.. It received FDA 510(k) clearance on 1990-01-02 under 510(k) number K896416. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYONICS SHOULDER PORTAL SYSTEM?

DYONICS SHOULDER PORTAL SYSTEM is a medical device that received FDA 510(k) clearance on 1990-01-02. The listed applicant is Dyonics, Inc.. The 510(k) number is K896416.

When did DYONICS SHOULDER PORTAL SYSTEM receive FDA 510(k) clearance?

DYONICS SHOULDER PORTAL SYSTEM received FDA 510(k) clearance on 1990-01-02, under 510(k) number K896416.

Who is the listed applicant for DYONICS SHOULDER PORTAL SYSTEM?

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

What is the FDA product code for DYONICS SHOULDER PORTAL SYSTEM?

The FDA product code for DYONICS SHOULDER PORTAL SYSTEM is HRX.

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Other records listing Dyonics, Inc. as applicant

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.

K900070MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEMK893136SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTYK890665MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIESK894728DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFEK892062PS3500 ARTHROSCOPIC SURGICAL SYSTEMK884839MODIFIED SAW BLADES TO THE SAGITAL SAW

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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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