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FDA 510(k)

Stryker Self-Punching ICONIX

K-Number: K171465 · 2017-08-24

ApplicantStryker
Decision Date2017-08-24
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stryker Self-Punching ICONIX is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2017-08-24 under 510(k) number K171465. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker Self-Punching ICONIX?

Stryker Self-Punching ICONIX is a medical device that received FDA 510(k) clearance on 2017-08-24. The listed applicant is Stryker. The 510(k) number is K171465.

When did Stryker Self-Punching ICONIX receive FDA 510(k) clearance?

Stryker Self-Punching ICONIX received FDA 510(k) clearance on 2017-08-24, under 510(k) number K171465.

Who is the listed applicant for Stryker Self-Punching ICONIX?

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

What is the FDA product code for Stryker Self-Punching ICONIX?

The FDA product code for Stryker Self-Punching ICONIX is MBI.

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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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