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FDA 510(k)

ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM

K-Number: K101997 · 2011-07-12

ApplicantEllipse Technologies, Inc.
Decision Date2011-07-12
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ELLIPSE INTRAMEDULLARY LIMB LENGTHENING 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 2011-07-12 under 510(k) number K101997. 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 INTRAMEDULLARY LIMB LENGTHENING SYSTEM?

ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-12. The listed applicant is Ellipse Technologies, Inc.. The 510(k) number is K101997.

When did ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM receive FDA 510(k) clearance?

ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM received FDA 510(k) clearance on 2011-07-12, under 510(k) number K101997.

Who is the listed applicant for ELLIPSE INTRAMEDULLARY LIMB LENGTHENING 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 INTRAMEDULLARY LIMB LENGTHENING SYSTEM?

The FDA product code for ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM is HSB.

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Other records listing Ellipse Technologies, 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.

K160325PRECICE Intramedullary Limb Lengthening SystemK133289PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMK131677PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMK113219ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMK113695ELLIPSE PRECICE TRAUMA NAIL SYSTEM

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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