PLLA, HA SCREW— 510(k) K080358

Substantially Equivalent

Smith & Nephew Inc., Endoscopy Div.

FDA 510(k) clearance K080358 for PLLA, HA SCREW, Substantially Equivalent on 2008-04-23. Applicant: Smith & Nephew Inc., Endoscopy Div..

Clearance details

Applicant: Smith & Nephew Inc., Endoscopy Div.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2008-02-11
Decision date: 2008-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.