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FDA 510(k)

IFS Fixation Scaffold System

K-Number: K152627 · 2016-01-13

ApplicantMetric Medical Devices, Inc.
Decision Date2016-01-13
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IFS Fixation Scaffold System is the device name listed in this FDA 510(k) record. The listed applicant is Metric Medical Devices, Inc.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K152627. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IFS Fixation Scaffold System?

IFS Fixation Scaffold System is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Metric Medical Devices, Inc.. The 510(k) number is K152627.

When did IFS Fixation Scaffold System receive FDA 510(k) clearance?

IFS Fixation Scaffold System received FDA 510(k) clearance on 2016-01-13, under 510(k) number K152627.

Who is the listed applicant for IFS Fixation Scaffold System?

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

What is the FDA product code for IFS Fixation Scaffold System?

The FDA product code for IFS Fixation Scaffold System is HTY.

Other records listing Metric Medical Devices, 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.

K240049LINK(TM) External Fixator

Related Devices (Code: HTY)

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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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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