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FDA 510(k)

FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS

K-Number: K091812 · 2010-05-07

ApplicantFrontier Devices, Inc.
Decision Date2010-05-07
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Frontier Devices, Inc.. It received FDA 510(k) clearance on 2010-05-07 under 510(k) number K091812. 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 FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS?

FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS is a medical device that received FDA 510(k) clearance on 2010-05-07. The listed applicant is Frontier Devices, Inc.. The 510(k) number is K091812.

When did FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS receive FDA 510(k) clearance?

FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS received FDA 510(k) clearance on 2010-05-07, under 510(k) number K091812.

Who is the listed applicant for FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS?

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

What is the FDA product code for FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS?

The FDA product code for FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS 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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