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FDA 510(k)

RAPID IMF

K-Number: K030605 · 2003-06-27

ApplicantZygomatics , Ltd.
Decision Date2003-06-27
Product CodeDYX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RAPID IMF is the device name listed in this FDA 510(k) record. The listed applicant is Zygomatics , Ltd.. It received FDA 510(k) clearance on 2003-06-27 under 510(k) number K030605. 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 RAPID IMF?

RAPID IMF is a medical device that received FDA 510(k) clearance on 2003-06-27. The listed applicant is Zygomatics , Ltd.. The 510(k) number is K030605.

When did RAPID IMF receive FDA 510(k) clearance?

RAPID IMF received FDA 510(k) clearance on 2003-06-27, under 510(k) number K030605.

Who is the listed applicant for RAPID IMF?

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

What is the FDA product code for RAPID IMF?

The FDA product code for RAPID IMF is DYX.

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Related Devices (Code: DYX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162046MINNE TIES MMF Suture SystemSummit Medical, Inc.K061271ERCH ARCH BAR, MODEL 38-690-00KLS-Martin L.P.K031207SAFETY RELEASE ARCH BAR KITCasey Surgical, LLCK990212LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00Doctor'S Research Group, Inc.K991004SYNTHES QUICK LOCK IMF SYSTEMSynthes (Usa)K925106IMPLANTABLE PULSE GENERATORSMedtronic Vascular

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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