Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Custom Orthopaedic Solutions with 8 510(k) clearances. The most recent is a 510(k) clearance dated Feb 10, 2017: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Pl….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 10, 2017 | Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web PortalK162697 · KWS | 510(k) clearances |
| Mar 15, 2016 | ArthrexVIP Web PortalK153612 · LLZ | 510(k) clearances |
| Feb 19, 2016 | SmartBase for Arthrex Glenoid IRISK153215 · KWS | 510(k) clearances |
| Oct 5, 2015 | Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)K151500 · KWS | 510(k) clearances |
| Oct 2, 2015 | OrthoVis Web PortalK151501 · LLZ | 510(k) clearances |
| Jul 31, 2015 | Arthrex OrthoVis Preoperative PlanK151568 · LLZ | 510(k) clearances |
| Nov 24, 2014 | GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)K142072 · KWS | 510(k) clearances |
| Dec 20, 2013 | ORTHOVIS PREOPERATIVE PLANK133367 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
