IMPLEX ACETABULAR CUP SCREW SYSTEM— 510(k) K931187

Substantially Equivalent

Implex Corp.

FDA 510(k) clearance K931187 for IMPLEX ACETABULAR CUP SCREW SYSTEM, Substantially Equivalent on 1994-02-07. Applicant: Implex Corp..

Clearance details

Applicant: Implex Corp.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1993-03-09
Decision date: 1994-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, 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.