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FDA 510(k)

ORTRAUTEK ORTHOGNATHIC SYSTEM

K-Number: K031989 · 2003-10-28

ApplicantTekka
Decision Date2003-10-28
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTRAUTEK ORTHOGNATHIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tekka. It received FDA 510(k) clearance on 2003-10-28 under 510(k) number K031989. 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 ORTRAUTEK ORTHOGNATHIC SYSTEM?

ORTRAUTEK ORTHOGNATHIC SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-28. The listed applicant is Tekka. The 510(k) number is K031989.

When did ORTRAUTEK ORTHOGNATHIC SYSTEM receive FDA 510(k) clearance?

ORTRAUTEK ORTHOGNATHIC SYSTEM received FDA 510(k) clearance on 2003-10-28, under 510(k) number K031989.

Who is the listed applicant for ORTRAUTEK ORTHOGNATHIC SYSTEM?

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

What is the FDA product code for ORTRAUTEK ORTHOGNATHIC SYSTEM?

The FDA product code for ORTRAUTEK ORTHOGNATHIC SYSTEM is JEY.

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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Other records listing Tekka as applicant

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.

K032520ORTRAUTEK TRAUMA SYSTEM

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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