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FDA 510(k)

Tandry CMF Plate System

K-Number: K220360 · 2022-11-10

ApplicantMicroware Precision Co., Ltd.
Decision Date2022-11-10
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Tandry CMF Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Microware Precision Co., Ltd.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K220360. 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 Tandry CMF Plate System?

Tandry CMF Plate System is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Microware Precision Co., Ltd.. The 510(k) number is K220360.

When did Tandry CMF Plate System receive FDA 510(k) clearance?

Tandry CMF Plate System received FDA 510(k) clearance on 2022-11-10, under 510(k) number K220360.

Who is the listed applicant for Tandry CMF Plate System?

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

What is the FDA product code for Tandry CMF Plate System?

The FDA product code for Tandry CMF Plate System is JEY.

Other records listing Microware Precision 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.

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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.

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.K240651MRI UniversalStryker Leibinger GmbH & Co KG

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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