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FDA 510(k)

MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER

K-Number: K934366 · 1994-10-07

ApplicantMitek Surgical Products, Inc.
Decision Date1994-10-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Surgical Products, Inc.. It received FDA 510(k) clearance on 1994-10-07 under 510(k) number K934366. 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 MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER?

MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER is a medical device that received FDA 510(k) clearance on 1994-10-07. The listed applicant is Mitek Surgical Products, Inc.. The 510(k) number is K934366.

When did MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER receive FDA 510(k) clearance?

MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER received FDA 510(k) clearance on 1994-10-07, under 510(k) number K934366.

Who is the listed applicant for MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER?

The FDA 510(k) record lists Mitek Surgical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER?

The FDA product code for MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER is HWC. This falls under the Cardiovascular category.

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Other records listing Mitek Surgical Products, 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.

K953560MITEK THREADED ANCHOR (FASTIN)K953877MITEK GII ANCHORK936311MITEK MINI ANCHORK941599MITEK ABSORBABLE ANCHORK944051ABSORBALBE ANCHORK950070MITEK TOGGLE ANCHOR(TM)

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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