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FDA 510(k)

INTRA-ARTICULAR SURGICAL SYSTEM

K-Number: K820367 · 1982-05-07

ApplicantDyonics, Inc.
Decision Date1982-05-07
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTRA-ARTICULAR SURGICAL 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 1982-05-07 under 510(k) number K820367. The device is classified under product code KIJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRA-ARTICULAR SURGICAL SYSTEM?

INTRA-ARTICULAR SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1982-05-07. The listed applicant is Dyonics, Inc.. The 510(k) number is K820367.

When did INTRA-ARTICULAR SURGICAL SYSTEM receive FDA 510(k) clearance?

INTRA-ARTICULAR SURGICAL SYSTEM received FDA 510(k) clearance on 1982-05-07, under 510(k) number K820367.

Who is the listed applicant for INTRA-ARTICULAR SURGICAL 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 INTRA-ARTICULAR SURGICAL SYSTEM?

The FDA product code for INTRA-ARTICULAR SURGICAL SYSTEM is KIJ.

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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: KIJ)

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.

K163308SMARTOJeil Medical CorporationK112599INSURGICAL SINGLE USE POWER EQUIPMENTInsurgical, LLCK101563SMARTOJeil Medical CorporationK972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTStryker InstrumentsK970378STRYKER 2115 REPLACEMENT BATTERY (2115)Implant Resource, Inc.K960711ACUMED BONE GRAFT SYSTEMAcu Med, 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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