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FDA 510(k)

INTRA-ARTICULAR SHAVER

K-Number: K771218 · 1978-02-01

ApplicantDyonics, Inc.
Decision Date1978-02-01
Product CodeKIJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTRA-ARTICULAR SHAVER is the device name listed in this FDA 510(k) record. The listed applicant is Dyonics, Inc.. It received FDA 510(k) clearance on 1978-02-01 under 510(k) number K771218. 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 SHAVER?

INTRA-ARTICULAR SHAVER is a medical device that received FDA 510(k) clearance on 1978-02-01. The listed applicant is Dyonics, Inc.. The 510(k) number is K771218.

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

INTRA-ARTICULAR SHAVER received FDA 510(k) clearance on 1978-02-01, under 510(k) number K771218.

Who is the listed applicant for INTRA-ARTICULAR SHAVER?

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 SHAVER?

The FDA product code for INTRA-ARTICULAR SHAVER 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.

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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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