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FDA 510(k)

SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM

K-Number: K072463 · 2007-11-29

ApplicantSatyrne Medical
Decision Date2007-11-29
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Satyrne Medical. It received FDA 510(k) clearance on 2007-11-29 under 510(k) number K072463. 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 SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM?

SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-11-29. The listed applicant is Satyrne Medical. The 510(k) number is K072463.

When did SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM receive FDA 510(k) clearance?

SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM received FDA 510(k) clearance on 2007-11-29, under 510(k) number K072463.

Who is the listed applicant for SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM?

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

What is the FDA product code for SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM?

The FDA product code for SATYRNE INTERFLEX MANDIBULAR FIXATION SYSTEM is JEY.

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Related Devices (Code: JEY)

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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

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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