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FDA 510(k)

ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER

K-Number: K052086 · 2005-08-31

ApplicantEncore Medical, Inc.
Decision Date2005-08-31
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical, Inc.. It received FDA 510(k) clearance on 2005-08-31 under 510(k) number K052086. 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 ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER?

ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER is a medical device that received FDA 510(k) clearance on 2005-08-31. The listed applicant is Encore Medical, Inc.. The 510(k) number is K052086.

When did ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER receive FDA 510(k) clearance?

ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER received FDA 510(k) clearance on 2005-08-31, under 510(k) number K052086.

Who is the listed applicant for ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER?

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

What is the FDA product code for ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER?

The FDA product code for ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER is PHX.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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