ACSYS SHEARER ACETABULAR CUP PROSTHESIS— 510(k) K900435

Substantially Equivalent

3M Company

FDA 510(k) clearance K900435 for ACSYS SHEARER ACETABULAR CUP PROSTHESIS, Substantially Equivalent on 1990-09-14. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 1990-01-30
Decision date: 1990-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cottae Grove, MN, US

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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.