510(k) Report

Devices descending from K962913

10 later devices reach Synthes Sterile Drill Bits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161704Phasor DrillBiotex, Inc.201641
+1K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes201332
+1K102743Ortho Solutions - Sterile, Drills, Taps, Guide Pins & WiresOrtho Solutions Limited20110—
+2K252696LegacyPhasor Health, LLC20250—
+2K252060GREENPhasor Health, LLC20250—
+2K230619Hubly Electric Drill (H100)Hubly, Inc.20231—
+2K171911Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc.20170—
+2K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc.20141—
+3K250815Hubly Drill (H100)Hubly, Inc.20250—
+3K232897Arthrex Small External Fixation SystemArthrex, Inc.20230—