THREADED FIXATION PIN— 510(k) K982931

Substantially Equivalent

Sgarlato Laboratories, Inc.

FDA 510(k) clearance K982931 for THREADED FIXATION PIN, Substantially Equivalent on 1998-10-21. Applicant: Sgarlato Laboratories, Inc..

Clearance details

Applicant: Sgarlato Laboratories, Inc.
Product code: Code JDW
Advisory panel: Orthopedic
Date received: 1998-08-20
Decision date: 1998-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Gatos, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.