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FDA 510(k)

JAW FIXATION ASSEMBLY

K-Number: K863799 · 1986-10-14

ApplicantMedical Products & Research, Inc.
Decision Date1986-10-14
Product CodeDYX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JAW FIXATION ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Medical Products & Research, Inc.. It received FDA 510(k) clearance on 1986-10-14 under 510(k) number K863799. 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 JAW FIXATION ASSEMBLY?

JAW FIXATION ASSEMBLY is a medical device that received FDA 510(k) clearance on 1986-10-14. The listed applicant is Medical Products & Research, Inc.. The 510(k) number is K863799.

When did JAW FIXATION ASSEMBLY receive FDA 510(k) clearance?

JAW FIXATION ASSEMBLY received FDA 510(k) clearance on 1986-10-14, under 510(k) number K863799.

Who is the listed applicant for JAW FIXATION ASSEMBLY?

The FDA 510(k) record lists Medical Products & Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAW FIXATION ASSEMBLY?

The FDA product code for JAW FIXATION ASSEMBLY is DYX.

Related Clinical Trials

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.

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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, LLCK030605RAPID IMFZygomatics , Ltd.K990212LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00Doctor'S Research Group, Inc.K991004SYNTHES QUICK LOCK IMF SYSTEMSynthes (Usa)

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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