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FDA 510(k)

ELLIPSE PRECICE TRAUMA NAIL SYSTEM

K-Number: K113695 · 2012-03-28

ApplicantEllipse Technologies, Inc.
Decision Date2012-03-28
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ELLIPSE PRECICE TRAUMA NAIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ellipse Technologies, Inc.. It received FDA 510(k) clearance on 2012-03-28 under 510(k) number K113695. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELLIPSE PRECICE TRAUMA NAIL SYSTEM?

ELLIPSE PRECICE TRAUMA NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-28. The listed applicant is Ellipse Technologies, Inc.. The 510(k) number is K113695.

When did ELLIPSE PRECICE TRAUMA NAIL SYSTEM receive FDA 510(k) clearance?

ELLIPSE PRECICE TRAUMA NAIL SYSTEM received FDA 510(k) clearance on 2012-03-28, under 510(k) number K113695.

Who is the listed applicant for ELLIPSE PRECICE TRAUMA NAIL SYSTEM?

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

What is the FDA product code for ELLIPSE PRECICE TRAUMA NAIL SYSTEM?

The FDA product code for ELLIPSE PRECICE TRAUMA NAIL SYSTEM is HSB.

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Other records listing Ellipse Technologies, Inc. as applicant

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Related Devices (Code: HSB)

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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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