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FDA 510(k)

GUIDE TO THE KNEE

K-Number: K843121 · 1984-09-07

ApplicantDyonics, Inc.
Decision Date1984-09-07
Product CodeBWN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GUIDE TO THE KNEE is the device name listed in this FDA 510(k) record. The listed applicant is Dyonics, Inc.. It received FDA 510(k) clearance on 1984-09-07 under 510(k) number K843121. The device is classified under product code BWN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIDE TO THE KNEE?

GUIDE TO THE KNEE is a medical device that received FDA 510(k) clearance on 1984-09-07. The listed applicant is Dyonics, Inc.. The 510(k) number is K843121.

When did GUIDE TO THE KNEE receive FDA 510(k) clearance?

GUIDE TO THE KNEE received FDA 510(k) clearance on 1984-09-07, under 510(k) number K843121.

Who is the listed applicant for GUIDE TO THE KNEE?

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 GUIDE TO THE KNEE?

The FDA product code for GUIDE TO THE KNEE is BWN.

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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 SYSTEMK896416DYONICS SHOULDER PORTAL SYSTEMK893136SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTYK890665MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIESK894728DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFEK892062PS3500 ARTHROSCOPIC SURGICAL SYSTEM

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Related Devices (Code: BWN)

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K942699AIRFRAME SURGICAL DRAPE SUPPORTAlpha Surgical, Inc.K935441INFINITECH BREATH EZInfinitech, Inc.K925005ISI SELF-SUPPORTING ARMInstrumentation Specialties, Inc.K922288HOLDER, PEDIATRIC POSITIONYamashita and Hemsley Business TrustK910783SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604MSmith & Nephew Equipment GroupK902865BAUMER SURGICAL TABLESds Dental, Inc.

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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