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FDA 510(k)

THE ARTHROFILE

K-Number: K812506 · 1981-09-24

ApplicantDyonics, Inc.
Decision Date1981-09-24
Product CodeHTR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE ARTHROFILE is the device name listed in this FDA 510(k) record. The listed applicant is Dyonics, Inc.. It received FDA 510(k) clearance on 1981-09-24 under 510(k) number K812506. The device is classified under product code HTR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ARTHROFILE?

THE ARTHROFILE is a medical device that received FDA 510(k) clearance on 1981-09-24. The listed applicant is Dyonics, Inc.. The 510(k) number is K812506.

When did THE ARTHROFILE receive FDA 510(k) clearance?

THE ARTHROFILE received FDA 510(k) clearance on 1981-09-24, under 510(k) number K812506.

Who is the listed applicant for THE ARTHROFILE?

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 THE ARTHROFILE?

The FDA product code for THE ARTHROFILE is HTR.

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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: HTR)

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.

K870333BIODYNAMICS SMALL JOINT BRUSH #1203Biodynamic Technologies, Inc.K870329ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202Biodynamic Technologies, Inc.K870349BIODYNAMICS FEMORAL CANAL BRUSH #1201Biodynamic Technologies, Inc.K813093RICHARDS ACETABULAR BRUSHRichard'S Medical Equip., Inc.K780771MICRO RASPSAmsco Co.K771016INTERMEDULLARY BRUSHHowmedica Corp.

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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