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FDA 510(k)

IFS BONE FIXATION DEVICES

K-Number: K071035 · 2007-08-13

ApplicantInternal Fixation Systems, Inc.
Decision Date2007-08-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IFS BONE FIXATION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Internal Fixation Systems, Inc.. It received FDA 510(k) clearance on 2007-08-13 under 510(k) number K071035. 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 IFS BONE FIXATION DEVICES?

IFS BONE FIXATION DEVICES is a medical device that received FDA 510(k) clearance on 2007-08-13. The listed applicant is Internal Fixation Systems, Inc.. The 510(k) number is K071035.

When did IFS BONE FIXATION DEVICES receive FDA 510(k) clearance?

IFS BONE FIXATION DEVICES received FDA 510(k) clearance on 2007-08-13, under 510(k) number K071035.

Who is the listed applicant for IFS BONE FIXATION DEVICES?

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

What is the FDA product code for IFS BONE FIXATION DEVICES?

The FDA product code for IFS BONE FIXATION DEVICES is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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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Other records listing Internal Fixation Systems, 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.

K113399IFS SUBTALAR IMPLANTK110086IFS PROFILE PLATES, SCREWS, AND WASHERSK061620IFS CANNULATED BONE SCREW

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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