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FDA 510(k)

ECLIPSE TOTAL ANKLE IMPLANT

K-Number: K061749 · 2006-11-22

ApplicantKinetikos Medical, Inc.
Decision Date2006-11-22
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ECLIPSE TOTAL ANKLE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Kinetikos Medical, Inc.. It received FDA 510(k) clearance on 2006-11-22 under 510(k) number K061749. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECLIPSE TOTAL ANKLE IMPLANT?

ECLIPSE TOTAL ANKLE IMPLANT is a medical device that received FDA 510(k) clearance on 2006-11-22. The listed applicant is Kinetikos Medical, Inc.. The 510(k) number is K061749.

When did ECLIPSE TOTAL ANKLE IMPLANT receive FDA 510(k) clearance?

ECLIPSE TOTAL ANKLE IMPLANT received FDA 510(k) clearance on 2006-11-22, under 510(k) number K061749.

Who is the listed applicant for ECLIPSE TOTAL ANKLE IMPLANT?

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

What is the FDA product code for ECLIPSE TOTAL ANKLE IMPLANT?

The FDA product code for ECLIPSE TOTAL ANKLE IMPLANT is HSN.

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Other records listing Kinetikos Medical, 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.

K061465KMI CEMENT RESTRICTOR IMPLANTK051611MBARESORB IMPLANTK041461KMI DISTAL VOLAR RADIUS PLATE SYSTEMK032806KATALYST RADIAL HEAD IMPLANTK040356KOMPRESSOR SCREW SYSTEMK024233KOMPRESSOR SCREW SYSTEM

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Related Devices (Code: HSN)

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.

K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3DK250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.K240475Hintermann Series H2 Total Ankle SystemVilex, LLCK241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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