FDA 510(k)

SIGNATURE PLANNER,SIGNATURE GUIDES

K-Number: K111863 · 2012-06-15

Decision Date2012-06-15

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SIGNATURE PLANNER,SIGNATURE GUIDES is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2012-06-15 under 510(k) number K111863. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNATURE PLANNER,SIGNATURE GUIDES?

SIGNATURE PLANNER,SIGNATURE GUIDES is a medical device that received FDA 510(k) clearance on 2012-06-15. The listed applicant is Materialise NV. The 510(k) number is K111863.

When did SIGNATURE PLANNER,SIGNATURE GUIDES receive FDA 510(k) clearance?

SIGNATURE PLANNER,SIGNATURE GUIDES received FDA 510(k) clearance on 2012-06-15, under 510(k) number K111863.

Who is the listed applicant for SIGNATURE PLANNER,SIGNATURE GUIDES?

The FDA 510(k) record lists Materialise NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGNATURE PLANNER,SIGNATURE GUIDES?

The FDA product code for SIGNATURE PLANNER,SIGNATURE GUIDES is JDI.

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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.