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FDA 510(k)

ASCENSION ANKLE FUSION NAIL SYSTEM

K-Number: K100925 · 2010-07-12

ApplicantAscension Orthopedics, Inc.
Decision Date2010-07-12
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASCENSION ANKLE FUSION NAIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ascension Orthopedics, Inc.. It received FDA 510(k) clearance on 2010-07-12 under 510(k) number K100925. 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 ASCENSION ANKLE FUSION NAIL SYSTEM?

ASCENSION ANKLE FUSION NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-12. The listed applicant is Ascension Orthopedics, Inc.. The 510(k) number is K100925.

When did ASCENSION ANKLE FUSION NAIL SYSTEM receive FDA 510(k) clearance?

ASCENSION ANKLE FUSION NAIL SYSTEM received FDA 510(k) clearance on 2010-07-12, under 510(k) number K100925.

Who is the listed applicant for ASCENSION ANKLE FUSION NAIL SYSTEM?

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

What is the FDA product code for ASCENSION ANKLE FUSION NAIL SYSTEM?

The FDA product code for ASCENSION ANKLE FUSION NAIL SYSTEM is HSB.

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Related Devices (Code: HSB)

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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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