Medical device makerLabelled 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 New Standard Device Inc with 4 device recalls and 2 510(k) clearances. The most recent is a 510(k) clearance dated May 30, 2024: Revolution External Plating System.
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.
| May 30, 2024 | Revolution External Plating SystemK233025 · KTT | 510(k) clearances |
| Dec 28, 2020 | Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30Class II · Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery. | Device recalls |
| Jun 8, 2020 | 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating SystemClass II · 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and | Device recalls |
| Aug 14, 2019 | Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618AClass II · Due to manufacturing processing error, wrench causing stripping when torqueing nuts. | Device recalls |
| Jul 23, 2019 | 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 10080Class II · The threads on posts stripping out when tensioned during application process. | Device recalls |
| May 29, 2019 | Revolution External Plating SystemK181630 · KTT | 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
