FDA 510(k)

AltiVate Anatomic Canal-Sparing (CS) Shoulder

Número K: K193226 · 2020-06-03

Data da decisão2020-06-03

Código do produtoPKC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AltiVate Anatomic Canal-Sparing (CS) Shoulder is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2020-06-03 under 510(k) number K193226. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AltiVate Anatomic Canal-Sparing (CS) Shoulder?

AltiVate Anatomic Canal-Sparing (CS) Shoulder is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is Encore Medical L.P.. The 510(k) number is K193226.

When did AltiVate Anatomic Canal-Sparing (CS) Shoulder receive FDA 510(k) clearance?

AltiVate Anatomic Canal-Sparing (CS) Shoulder received FDA 510(k) clearance on 2020-06-03, under 510(k) number K193226.

Who is the listed applicant for AltiVate Anatomic Canal-Sparing (CS) Shoulder?

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

What is the FDA product code for AltiVate Anatomic Canal-Sparing (CS) Shoulder?

The FDA product code for AltiVate Anatomic Canal-Sparing (CS) Shoulder is PKC.

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Outros registros que listam Encore Medical L.P. como candidato(a)

K252567AltiVate Reverse® ADLC Glenosphere K252974EMPOWR Knee K251833EMPOWR Acetabular® Liner Extension K252141AltiVate Reverse® Glenoid K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

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Fonte oficial

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