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FDA 510(k)

DYONICS FIXATION SCREWS

K-Number: K945182 · 1995-01-24

ApplicantSmith & Nephew Dyonics, Inc.
Decision Date1995-01-24
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DYONICS FIXATION SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Dyonics, Inc.. It received FDA 510(k) clearance on 1995-01-24 under 510(k) number K945182. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DYONICS FIXATION SCREWS?

DYONICS FIXATION SCREWS is a medical device that received FDA 510(k) clearance on 1995-01-24. The listed applicant is Smith & Nephew Dyonics, Inc.. The 510(k) number is K945182.

When did DYONICS FIXATION SCREWS receive FDA 510(k) clearance?

DYONICS FIXATION SCREWS received FDA 510(k) clearance on 1995-01-24, under 510(k) number K945182.

Who is the listed applicant for DYONICS FIXATION SCREWS?

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

What is the FDA product code for DYONICS FIXATION SCREWS?

The FDA product code for DYONICS FIXATION SCREWS is HWC. This falls under the Cardiovascular category.

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Other records listing Smith & Nephew 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.

K955914LIMITED REUSE ARTHROSCOPIC BLADESK954627ECTRA II LIGAMENT RELEASE SYSTEMK954989DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADESK953695DYONICS DISPOSABLE ARTHROSCOPIC BLADESK953387ECTRA LIGAMENT RELEASE SYSTEMK936071SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE

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Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, 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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