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FDA 510(k)

IFS SUBTALAR IMPLANT

K-Number: K113399 · 2011-12-20

ApplicantInternal Fixation Systems, Inc.
Decision Date2011-12-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IFS SUBTALAR IMPLANT 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 2011-12-20 under 510(k) number K113399. 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 SUBTALAR IMPLANT?

IFS SUBTALAR IMPLANT is a medical device that received FDA 510(k) clearance on 2011-12-20. The listed applicant is Internal Fixation Systems, Inc.. The 510(k) number is K113399.

When did IFS SUBTALAR IMPLANT receive FDA 510(k) clearance?

IFS SUBTALAR IMPLANT received FDA 510(k) clearance on 2011-12-20, under 510(k) number K113399.

Who is the listed applicant for IFS SUBTALAR IMPLANT?

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 SUBTALAR IMPLANT?

The FDA product code for IFS SUBTALAR IMPLANT 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.

K110086IFS PROFILE PLATES, SCREWS, AND WASHERSK071035IFS BONE FIXATION DEVICESK061620IFS 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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