510(k) Report

Devices descending from K011711

13 later devices reach Modification to Ebi Efix Vision Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma200821
+1K033635Modification to Ebi Xfix Vision Fixation SystemEbi, L.P.20034—
+1K020141Modification to Ebi Xfix Vision Fixation SystemEbi, L.P.20029—
+1K014194Modification to Ebi Xfix Vision Fixation SystemEbi, L.P.200211—
+2K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V20130—
+2K102843Mac Male AdapterBiomet Trauma (Aka Ebi, LLC)20110—
+2K040833Modification to Ebi Xfix Vision Fixation SystemEbi, L.P.20043—
+2K021031Ebi Xfix Rail SystemEbi, L.P.20028—
+3K031875Inter-OS Limb LengthenerInter-Os Technologies20034—
+4K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+4K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc.20050—
+5K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+5K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—