510(k) Report

Devices descending from K082032

29 later devices reach Sequoia Spinal System (Model 3306), Speedlink Transverse Connector (Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+1K131980Sequoia Pedicle Screw System Including Speedlink II Transverse Connector SystemZimmer Spine, Inc.201310—
+1K123552Instinct Java SystemZimmer Spine201301
+1K122592Instinct Java SystemZimmer Spine201301
+1K113270Instinct Java SystemZimmer Spine201121
+1K111301Instinct Java SystemZimmer Spine201131
+1K101682S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC20108—
+1K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+2K203507Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.20218—
+2K201568Calvary Spine Pedicle Screw SystemCalvary Spine, LLC20200—
+2K162764Jazz Frame SystemImplanet, S.A.20176—
+2K142752Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…Zimmer Spine, Inc.20150—
+2K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+2K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K230116Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20235—
+3K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+3K171881JAZZ Passer BandImplanet, S.A.20170—
+3K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+3K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+4K240539Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20244—
+4K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—