ClearanceBrief
510(k) K161840 · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated

ApplicantWaldemar Link GmbH & Co. KG, Norderstedt, DE
DecisionSubstantially Equivalent, Mar 16, 2017
ReceivedJul 5, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K161840

No recall in the FDA data names this 510(k).

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