ClearanceBrief
510(k) K002652 ยท LOD Bone Cement

SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII

ApplicantStryker Corp., Portage MI, US
DecisionSubstantially Equivalent, Jan 26, 2001
ReceivedAug 25, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K002652

DateFirm and productCodeLinked 510(k)
Dec 20, 2022Howmedica Osteonics Corp.
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
Open, Classified
LODNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.