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FDA 510(k)

SAFETY RELEASE ARCH BAR KIT

K-Number: K031207 · 2003-07-15

ApplicantCasey Surgical, LLC
Decision Date2003-07-15
Product CodeDYX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAFETY RELEASE ARCH BAR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Casey Surgical, LLC. It received FDA 510(k) clearance on 2003-07-15 under 510(k) number K031207. The device is classified under product code DYX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFETY RELEASE ARCH BAR KIT?

SAFETY RELEASE ARCH BAR KIT is a medical device that received FDA 510(k) clearance on 2003-07-15. The listed applicant is Casey Surgical, LLC. The 510(k) number is K031207.

When did SAFETY RELEASE ARCH BAR KIT receive FDA 510(k) clearance?

SAFETY RELEASE ARCH BAR KIT received FDA 510(k) clearance on 2003-07-15, under 510(k) number K031207.

Who is the listed applicant for SAFETY RELEASE ARCH BAR KIT?

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

What is the FDA product code for SAFETY RELEASE ARCH BAR KIT?

The FDA product code for SAFETY RELEASE ARCH BAR KIT is DYX.

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Related Devices (Code: DYX)

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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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