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FDA 510(k)

REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM

K-Number: K103208 · 2011-01-31

ApplicantEncore Medical L.P.
Decision Date2011-01-31
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM 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 2011-01-31 under 510(k) number K103208. 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 PROSTHESIS MONOBLOCK STEM?

REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM is a medical device that received FDA 510(k) clearance on 2011-01-31. The listed applicant is Encore Medical L.P.. The 510(k) number is K103208.

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

REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM received FDA 510(k) clearance on 2011-01-31, under 510(k) number K103208.

Who is the listed applicant for REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM?

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 PROSTHESIS MONOBLOCK STEM?

The FDA product code for REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM is 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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