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FDA 510(k)

GAMMA3 AND T2 RECON TARGETING DEVICES

K-Number: K123401 · 2013-01-23

ApplicantStryker Trauma AG
Decision Date2013-01-23
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GAMMA3 AND T2 RECON TARGETING DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Trauma AG. It received FDA 510(k) clearance on 2013-01-23 under 510(k) number K123401. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA3 AND T2 RECON TARGETING DEVICES?

GAMMA3 AND T2 RECON TARGETING DEVICES is a medical device that received FDA 510(k) clearance on 2013-01-23. The listed applicant is Stryker Trauma AG. The 510(k) number is K123401.

When did GAMMA3 AND T2 RECON TARGETING DEVICES receive FDA 510(k) clearance?

GAMMA3 AND T2 RECON TARGETING DEVICES received FDA 510(k) clearance on 2013-01-23, under 510(k) number K123401.

Who is the listed applicant for GAMMA3 AND T2 RECON TARGETING DEVICES?

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

What is the FDA product code for GAMMA3 AND T2 RECON TARGETING DEVICES?

The FDA product code for GAMMA3 AND T2 RECON TARGETING DEVICES is HSB.

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Related Devices (Code: HSB)

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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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