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FDA 510(k)

DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS

K-Number: K062116 · 2006-08-18

ApplicantDePuy Orthopaedics, Inc.
Decision Date2006-08-18
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DELTA CTA REVERSE SHOULDER SYSTEM 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 2006-08-18 under 510(k) number K062116. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS?

DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS is a medical device that received FDA 510(k) clearance on 2006-08-18. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K062116.

When did DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS receive FDA 510(k) clearance?

DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS received FDA 510(k) clearance on 2006-08-18, under 510(k) number K062116.

Who is the listed applicant for DELTA CTA REVERSE SHOULDER SYSTEM 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 DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS?

The FDA product code for DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS is PHX.

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Related Devices (Code: PHX)

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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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