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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K151739

Revision Femoral Stem · Lima Corporate S.P.A. · decided 2015-11-23 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
REVISION HipLateralized Trial Neck with ScrewLIMACORPORATE SPAKWY LPH LZO08033390112888
REVISION HipReamerLIMACORPORATE SPAKWY LPH LZO08033390039437
REVISION HipNeck Reamer GuideLIMACORPORATE SPAKWY LPH LZO08033390024150
REVISION HipTrial Neck with ScrewLIMACORPORATE SPAKWY LPH LZO08033390112833
REVISION HipTrial Neck With ScrewLIMACORPORATE SPAKWY LPH LZO08033390046800
REVISION HipDynamic ImpactorLIMACORPORATE SPAKWY LPH LZO08033390039482
REVISIONREVISION HIP - Ti6Al4VLIMACORPORATE SPAKWY LPH LZO08033390017817
REVISIONREVISION HIP - Ti6Al4VLIMACORPORATE SPAKWY LPH LZO08033390003896
REVISION Hip SystemReamerLIMACORPORATE SPAKWY LPH LZO08033390112703
REVISION HipTrial NeckLIMACORPORATE SPAKWY LPH LZO08033390024198
REVISIONREVISION HIP - Ti6Al4VLIMACORPORATE SPAKWY LPH LZO08033390003865
REVISION HipReamerLIMACORPORATE SPAKWY LPH LZO08033390024143
REVISION HipTrial Neck With ScrewLIMACORPORATE SPAKWY LPH LZO08033390039512
REVISION Hip SystemReamerLIMACORPORATE SPAKWY LPH LZO08033390112666
REVISION HipReamerLIMACORPORATE SPAKWY LPH LZO08033390039444
REVISION HipTrial NeckLIMACORPORATE SPAKWY LPH LZO08033390024242
REVISIONREVISION HIP - Ti6Al4VLIMACORPORATE SPAKWY LPH LZO08033390017749
REVISION Hip SystemReamerLIMACORPORATE SPAKWY LPH LZO08033390112796
REVISION Hip SystemReamerLIMACORPORATE SPAKWY LPH LZO08033390112741
REVISIONREVISION HIP - Ti6Al4VLIMACORPORATE SPAKWY LPH LZO08033390017770
REVISION HipNeck ReamerLIMACORPORATE SPAKWY LPH LZO08033390024167
REVISION HipReamerLIMACORPORATE SPAKWY LPH LZO08033390050715
REVISION HipTrial Neck with ScrewLIMACORPORATE SPAKWY LPH LZO08033390112871
REVISION HipTrial Neck With ScrewLIMACORPORATE SPAKWY LPH LZO08033390112819
REVISIONREVISION HIP - Ti6Al4VLIMACORPORATE SPAKWY LPH LZO08033390003872