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FDA 510(k)

FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)

K-Number: K081067 · 2008-05-09

ApplicantBiomet Microfixation, Inc.
Decision Date2008-05-09
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation, Inc.. It received FDA 510(k) clearance on 2008-05-09 under 510(k) number K081067. 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 FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)?

FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) is a medical device that received FDA 510(k) clearance on 2008-05-09. The listed applicant is Biomet Microfixation, Inc.. The 510(k) number is K081067.

When did FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) receive FDA 510(k) clearance?

FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) received FDA 510(k) clearance on 2008-05-09, under 510(k) number K081067.

Who is the listed applicant for FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)?

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

What is the FDA product code for FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)?

The FDA product code for FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) is JEY.

Related Clinical Trials

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Other records listing Biomet Microfixation, Inc. 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.

K111908BIOMET MICROFIXATION STERNAL CLOSURE SYSTEMK110574BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEMK091058ADKINS STRUTK071577BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER

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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