Custom Orthopaedic Solutions, Inc.

FDA Regulatory Profile

Custom Orthopaedic Solutions, Inc. has 0 FDA recalls, 0 inspections, 8 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Feb 10, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances8Oct 4, 2026Not statedCurrent
Inspections0Oct 27, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan…Feb 10, 2017
K153612ArthrexVIP Web PortalMar 15, 2016
K153215SmartBase for Arthrex Glenoid IRISFeb 19, 2016
K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Oct 5, 2015
K151501OrthoVis Web PortalOct 2, 2015
K151568Arthrex OrthoVis Preoperative PlanJul 31, 2015
K142072GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)Nov 24, 2014
K133367ORTHOVIS PREOPERATIVE PLANDec 20, 2013