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FDA 510(k)

DEPUY CTA REVERSE SHOULDER SYSTEM

K-Number: K122442 · 2012-09-06

ApplicantDepuy France
Decision Date2012-09-06
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY CTA REVERSE SHOULDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy France. It received FDA 510(k) clearance on 2012-09-06 under 510(k) number K122442. 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 DEPUY CTA REVERSE SHOULDER SYSTEM?

DEPUY CTA REVERSE SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-06. The listed applicant is Depuy France. The 510(k) number is K122442.

When did DEPUY CTA REVERSE SHOULDER SYSTEM receive FDA 510(k) clearance?

DEPUY CTA REVERSE SHOULDER SYSTEM received FDA 510(k) clearance on 2012-09-06, under 510(k) number K122442.

Who is the listed applicant for DEPUY CTA REVERSE SHOULDER SYSTEM?

The FDA 510(k) record lists Depuy France as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEPUY CTA REVERSE SHOULDER SYSTEM?

The FDA product code for DEPUY CTA REVERSE SHOULDER SYSTEM is PHX.

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Other records listing Depuy France as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120174DEPUT DELTA XTEND REVERSE SHOULDER

Related Devices (Code: PHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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