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

Clearance record K163397

SMR Hybrid Glenoid System · Lima Corporate S.P.A. · decided 2017-06-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
SMR Shoulder1379.59.302LIMACORPORATE SPAKWS KWT MBF PHX08033390267540
SMR Shoulder - Hybrid GlenoidTrial GlenoidLIMACORPORATE SPAKWS KWT MBF PHX08033390121262
SMR Shoulder1379.59.304LIMACORPORATE SPAKWS KWT MBF PHX08033390267564
SMR Shoulder Glenosphere LIMACORPORATE SPAKWS KWT MBF PHX08033390123129
SMR TT Hybrid Glenoid1379.59.232LIMACORPORATE SPAKWS KWT MBF PHX08033390121866
SMR Shoulder1379.59.210LIMACORPORATE SPAKWS KWT MBF PHX08033390267151
SMR Shoulder1379.59.102LIMACORPORATE SPAKWS KWT MBF PHX08033390266796
SMR Shoulder1379.59.103LIMACORPORATE SPAKWS KWT MBF PHX08033390266802
SMR Shoulder1379.59.212LIMACORPORATE SPAKWS KWT MBF PHX08033390267175
SMR Shoulder1379.59.114LIMACORPORATE SPAKWS KWT MBF PHX08033390266918
SMR Shoulder - Hybrid GlenoidK-Wire Positioning JigLIMACORPORATE SPAKWS KWT MBF PHX08033390124256
SMR Shoulder - Hybrid GlenoidBaseplate ExtractorLIMACORPORATE SPAKWS KWT MBF PHX08033390124232
SMR Shoulder - Hybrid GlenoidTrial GlenoidLIMACORPORATE SPAKWS KWT MBF PHX08033390121255
SMR TT Hybrid Glenoid1379.59.133LIMACORPORATE SPAKWS KWT MBF PHX08033390121637
SMR TT Hybrid Glenoid1379.59.134LIMACORPORATE SPAKWS KWT MBF PHX08033390121644
SMR TT Hybrid Glenoid1379.59.111LIMACORPORATE SPAKWS KWT MBF PHX08033390121569
SMR Shoulder - Hybrid GlenoidTrial GlenoidLIMACORPORATE SPAKWS KWT MBF PHX08033390121170
SMR Shoulder - Hybrid GlenoidGlenoid PositionerLIMACORPORATE SPAKWS KWT MBF PHX08033390121415
SMR Shoulder1379.59.234LIMACORPORATE SPAKWS KWT MBF PHX08033390267519
SMR Shoulder - Hybrid GlenoidGlenosphere Extraction InsertLIMACORPORATE SPAKWS KWT MBF PHX08033390124188
SMR TT Hybrid Glenoid1379.59.100LIMACORPORATE SPAKWS KWT MBF PHX08033390121002
SMR System1376.09.031LIMACORPORATE SPAKWS KWT MBF PHX08033390272339
SMR Shoulder1379.59.221LIMACORPORATE SPAKWS KWT MBF PHX08033390267229
SMR Shoulder - Hybrid GlenoidGlenosphere Insertion GuideLIMACORPORATE SPAKWS KWT MBF PHX08033390124201
SMR TT Hybrid Glenoid1379.59.321LIMACORPORATE SPAKWS KWT MBF PHX08033390121927