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 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Ascension Orthopedics with 36 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated May 30, 2024: Freedom Wrist Arthroplasty 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 | Freedom Wrist Arthroplasty SystemK233674 · JWJ | 510(k) clearances |
| Dec 14, 2023 | Ascension Silicone MCP; Ascension Silicone PIPK233670 · KYJ | 510(k) clearances |
| Dec 18, 2018 | Integra Salto Total Ankle SystemK182878 · HSN | 510(k) clearances |
| Nov 16, 2018 | Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WWClass III · The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Parti | Device recalls |
| Jul 14, 2017 | Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemK162153 · HWC | 510(k) clearances |
| Jul 6, 2016 | Integra External Fixation SystemK160830 · KTT | 510(k) clearances |
| Dec 23, 2015 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidK152047 · KWS | 510(k) clearances |
| Oct 29, 2015 | Integra DigiFuse Cannulated Intramedullary Fusion SystemK152527 · HWC | 510(k) clearances |
| Aug 31, 2015 | Integra Total Ankle Replacement SystemK151459 · HSN | 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
