POLY PLUG CEMENT RESTRICTOR— 510(k) K840242

Substantially Equivalent

Latham Manufacturer

FDA 510(k) clearance K840242 for POLY PLUG CEMENT RESTRICTOR, Substantially Equivalent on 1984-05-30. Applicant: Latham Manufacturer.

Clearance details

Applicant: Latham Manufacturer
Product code: Code JDS
Advisory panel: Orthopedic
Date received: 1984-01-20
Decision date: 1984-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDS

product code JDS

Injury: 1,776
Malfunction: 1,509
Total: 3,285

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.