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FDA 510(k)

STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM

K-Number: K123786 · 2013-04-09

ApplicantStryker
Decision Date2013-04-09
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2013-04-09 under 510(k) number K123786. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM?

STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-09. The listed applicant is Stryker. The 510(k) number is K123786.

When did STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM receive FDA 510(k) clearance?

STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM received FDA 510(k) clearance on 2013-04-09, under 510(k) number K123786.

Who is the listed applicant for STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM?

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 UNIVERSAL ORBITAL FLOOR SYSTEM?

The FDA product code for STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM is JEY.

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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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