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FDA 510(k)

DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS

K-Number: K033516 · 2003-12-03

ApplicantDePuy Orthopaedics, Inc.
Decision Date2003-12-03
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2003-12-03 under 510(k) number K033516. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS?

DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS is a medical device that received FDA 510(k) clearance on 2003-12-03. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K033516.

When did DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS receive FDA 510(k) clearance?

DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS received FDA 510(k) clearance on 2003-12-03, under 510(k) number K033516.

Who is the listed applicant for DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS?

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

What is the FDA product code for DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS?

The FDA product code for DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS is HSD.

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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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