FLEXIBLE PIN S SHAPED INTRAMED. SYSTEM— 510(k) K803196

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K803196 for FLEXIBLE PIN S SHAPED INTRAMED. SYSTEM, Substantially Equivalent on 1981-02-09. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 1980-12-16
Decision date: 1981-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.