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FDA 510(k)

OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM

K-Number: K061881 · 2007-03-14

ApplicantTakiron Co., Ltd.
Decision Date2007-03-14
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Takiron Co., Ltd.. It received FDA 510(k) clearance on 2007-03-14 under 510(k) number K061881. 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 OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM?

OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-14. The listed applicant is Takiron Co., Ltd.. The 510(k) number is K061881.

When did OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM receive FDA 510(k) clearance?

OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM received FDA 510(k) clearance on 2007-03-14, under 510(k) number K061881.

Who is the listed applicant for OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM?

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

What is the FDA product code for OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM?

The FDA product code for OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM is JEY.

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Other records listing Takiron Co., Ltd. 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.

K081390BIOACTIF OSTEOTRANS INTERFENCE SCREWK073006OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEMK073312OSTEOTRANS-OT SCREWK073311OSTEOTRANS-OT PINK062691COMPORUS

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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