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FDA 510(k)

CORTICAL BONE SCREW (EUROPEAN STYLE)

K-Number: K905357 · 1991-01-04

ApplicantO'Tec Corp.
Decision Date1991-01-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

CORTICAL BONE SCREW (EUROPEAN STYLE) is the device name listed in this FDA 510(k) record. The listed applicant is O'Tec Corp.. It received FDA 510(k) clearance on 1991-01-04 under 510(k) number K905357. 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 CORTICAL BONE SCREW (EUROPEAN STYLE)?

CORTICAL BONE SCREW (EUROPEAN STYLE) is a medical device that received FDA 510(k) clearance on 1991-01-04. The listed applicant is O'Tec Corp.. The 510(k) number is K905357.

When did CORTICAL BONE SCREW (EUROPEAN STYLE) receive FDA 510(k) clearance?

CORTICAL BONE SCREW (EUROPEAN STYLE) received FDA 510(k) clearance on 1991-01-04, under 510(k) number K905357.

Who is the listed applicant for CORTICAL BONE SCREW (EUROPEAN STYLE)?

The FDA 510(k) record lists O'Tec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORTICAL BONE SCREW (EUROPEAN STYLE)?

The FDA product code for CORTICAL BONE SCREW (EUROPEAN STYLE) is HWC. This falls under the Cardiovascular category.

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Other records listing O'Tec Corp. 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.

K943293SCC22/ SCC26 SHOWER COMMODE CHAIRK910093FUTURA FEMORAL HIP STEMK905333U.S. TYPE CRUCIATE SLOT BONE SCREWK905355BROAD SELF-COMPRESSING PLATEK905358CANCELLOUS SCREWK905347HAGIE PIN

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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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