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FDA 510(k)

GRIT BLASTED HUMERAL STEM

K-Number: K991603 · 1999-06-29

ApplicantEncore Orthopedics, Inc.
Decision Date1999-06-29
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GRIT BLASTED HUMERAL STEM 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 1999-06-29 under 510(k) number K991603. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRIT BLASTED HUMERAL STEM?

GRIT BLASTED HUMERAL STEM is a medical device that received FDA 510(k) clearance on 1999-06-29. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K991603.

When did GRIT BLASTED HUMERAL STEM receive FDA 510(k) clearance?

GRIT BLASTED HUMERAL STEM received FDA 510(k) clearance on 1999-06-29, under 510(k) number K991603.

Who is the listed applicant for GRIT BLASTED HUMERAL STEM?

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 GRIT BLASTED HUMERAL STEM?

The FDA product code for GRIT BLASTED HUMERAL STEM is KWT.

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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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