FDA 510(k)

AltiVate Reverse® ADLC Glenosphere

Número K: K252567 · 2026-01-15

Data da decisão2026-01-15

Código do produtoPHX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AltiVate Reverse® ADLC Glenosphere 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 2026-01-15 under 510(k) number K252567. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AltiVate Reverse® ADLC Glenosphere?

AltiVate Reverse® ADLC Glenosphere is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is Encore Medical L.P.. The 510(k) number is K252567.

When did AltiVate Reverse® ADLC Glenosphere receive FDA 510(k) clearance?

AltiVate Reverse® ADLC Glenosphere received FDA 510(k) clearance on 2026-01-15, under 510(k) number K252567.

Who is the listed applicant for AltiVate Reverse® ADLC Glenosphere?

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 Reverse® ADLC Glenosphere?

The FDA product code for AltiVate Reverse® ADLC Glenosphere is PHX.

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

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)K251184Sistema de Ombro Inversa AltiVate; Sistema de Ombro RSP; Sistema de Ombro SMR; Sistema Fêmur PRIMA; Sistema Glenoid PRIMA

Ver todos os 31 dispositivos →

Dispositivos Relacionados (Código: PHX)

K260556Veritas Shoulder SystemRestor3D K261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid e Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SA K253992Veritas Reverse Total Shoulder SystemRestor3D K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

Fonte oficial

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