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FDA 510(k)

Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers

K-Number: K172587 · 2017-09-18

ApplicantMedacta International S.A.
Decision Date2017-09-18
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers 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 2017-09-18 under 510(k) number K172587. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers?

Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers is a medical device that received FDA 510(k) clearance on 2017-09-18. The listed applicant is Medacta International S.A.. The 510(k) number is K172587.

When did Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers receive FDA 510(k) clearance?

Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers received FDA 510(k) clearance on 2017-09-18, under 510(k) number K172587.

Who is the listed applicant for Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers?

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 Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers?

The FDA product code for Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers is ODP.

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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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