FDA 510(k)

Tandry CMF Plate System

Número K: K220360 · 2022-11-10

Data da decisão2022-11-10

Código do produtoJEY

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Outros registros que listam Microware Precision Co., Ltd. como candidato(a)

K242814Tandry Q-Locking Plate System K230690Tandry Locking Plate System K220359Tandry Compression Screw System K182929BIO-RAY A-1 Anchor Screw System K171904Tandry Locking Plate System

Dispositivos Relacionados (Código: JEY)

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 Corporation K253373Southern 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 OY K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

Fonte oficial

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