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FDA 510(k)

Glenoid Polyaxial Non-locking Screws

K-Number: K181826 · 2018-12-10

ApplicantMedacta International S.A.
Decision Date2018-12-10
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Glenoid Polyaxial Non-locking Screws is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K181826. 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 Glenoid Polyaxial Non-locking Screws?

Glenoid Polyaxial Non-locking Screws is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Medacta International S.A.. The 510(k) number is K181826.

When did Glenoid Polyaxial Non-locking Screws receive FDA 510(k) clearance?

Glenoid Polyaxial Non-locking Screws received FDA 510(k) clearance on 2018-12-10, under 510(k) number K181826.

Who is the listed applicant for Glenoid Polyaxial Non-locking Screws?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Glenoid Polyaxial Non-locking Screws?

The FDA product code for Glenoid Polyaxial Non-locking Screws 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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