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FDA 510(k)

PLASMA SPRAYED SHOULDER

K-Number: K003324 · 2001-12-06

ApplicantEncore Orthopedics, Inc.
Decision Date2001-12-06
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLASMA SPRAYED SHOULDER 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 2001-12-06 under 510(k) number K003324. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASMA SPRAYED SHOULDER?

PLASMA SPRAYED SHOULDER is a medical device that received FDA 510(k) clearance on 2001-12-06. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K003324.

When did PLASMA SPRAYED SHOULDER receive FDA 510(k) clearance?

PLASMA SPRAYED SHOULDER received FDA 510(k) clearance on 2001-12-06, under 510(k) number K003324.

Who is the listed applicant for PLASMA SPRAYED SHOULDER?

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 PLASMA SPRAYED SHOULDER?

The FDA product code for PLASMA SPRAYED SHOULDER is KWS.

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Related Devices (Code: KWS)

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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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