OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners— 510(k) K191287

Name: FDA 510(k) clearance K191287
Creator: U.S. Food and Drug Administration
Published: 2019-07-16

Substantially Equivalent

Davol Inc., Subsidiary of C.R. Bard

FDA 510(k) clearance K191287 for OptiFix AT Absorbable Fixation System with Articulating Technology 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology 15 Fasteners, Substantially Equivalent on 2019-07-16. Applicant: Davol Inc., Subsidiary of C.R. Bard. Device class: 2.

Clearance details

Applicant: Davol Inc., Subsidiary of C.R. Bard
Product code: Code GDW
Device class: Class 2
Regulation: 21 CFR 878.4750
Advisory panel: General, Plastic Surgery
Date received: 2019-05-13
Decision date: 2019-07-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Warwick, RI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.