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FDA 510(k)

ULTIMAX ANKLE FUSION ROD SYSTEM

K-Number: K991790 · 1999-08-06

ApplicantEncore Orthopedics, Inc.
Decision Date1999-08-06
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ULTIMAX ANKLE FUSION ROD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 1999-08-06 under 510(k) number K991790. 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 ULTIMAX ANKLE FUSION ROD SYSTEM?

ULTIMAX ANKLE FUSION ROD SYSTEM is a medical device that received FDA 510(k) clearance on 1999-08-06. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K991790.

When did ULTIMAX ANKLE FUSION ROD SYSTEM receive FDA 510(k) clearance?

ULTIMAX ANKLE FUSION ROD SYSTEM received FDA 510(k) clearance on 1999-08-06, under 510(k) number K991790.

Who is the listed applicant for ULTIMAX ANKLE FUSION ROD SYSTEM?

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

What is the FDA product code for ULTIMAX ANKLE FUSION ROD SYSTEM?

The FDA product code for ULTIMAX ANKLE FUSION ROD SYSTEM is 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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