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FDA 510(k)

CONCEPT ENDOSTEAL FIXATION DEVICE

K-Number: K912640 · 1992-05-01

ApplicantConcept, Inc.
Decision Date1992-05-01
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONCEPT ENDOSTEAL FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1992-05-01 under 510(k) number K912640. 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.

Frequently Asked Questions

What is the CONCEPT ENDOSTEAL FIXATION DEVICE?

CONCEPT ENDOSTEAL FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 1992-05-01. The listed applicant is Concept, Inc.. The 510(k) number is K912640.

When did CONCEPT ENDOSTEAL FIXATION DEVICE receive FDA 510(k) clearance?

CONCEPT ENDOSTEAL FIXATION DEVICE received FDA 510(k) clearance on 1992-05-01, under 510(k) number K912640.

Who is the listed applicant for CONCEPT ENDOSTEAL FIXATION DEVICE?

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

What is the FDA product code for CONCEPT ENDOSTEAL FIXATION DEVICE?

The FDA product code for CONCEPT ENDOSTEAL FIXATION DEVICE is HWC. This falls under the Cardiovascular category.

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Other records listing Concept, 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.

K912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBEK881954CONCEPT POWER SYSTEM

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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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