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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 a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2018-12-10 under approval 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. It is manufactured by Medacta International S.A.. The 510(k) number is K181826.

When was Glenoid Polyaxial Non-locking Screws approved by the FDA?

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

What company makes Glenoid Polyaxial Non-locking Screws?

Glenoid Polyaxial Non-locking Screws is manufactured by Medacta International S.A..

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

The FDA product code for Glenoid Polyaxial Non-locking Screws is PHX.

Related Clinical Trials

NCT07408726 Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization NOT_YET_RECRUITING

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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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