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FDA 510(k)

REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)

K-Number: K111061 · 2011-07-20

ApplicantEncore Medical L.P.
Decision Date2011-07-20
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2011-07-20 under 510(k) number K111061. 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 REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)?

REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) is a medical device that received FDA 510(k) clearance on 2011-07-20. The listed applicant is Encore Medical L.P.. The 510(k) number is K111061.

When did REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) receive FDA 510(k) clearance?

REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) received FDA 510(k) clearance on 2011-07-20, under 510(k) number K111061.

Who is the listed applicant for REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)?

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

What is the FDA product code for REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)?

The FDA product code for REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) 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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