FOUNDATION TEXTURED STEM— 510(k) K952297

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K952297 for FOUNDATION TEXTURED STEM, Substantially Equivalent on 1995-07-17. Applicant: Encore Orthopedics, Inc..

Clearance details

Applicant: Encore Orthopedics, Inc.
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 1995-05-16
Decision date: 1995-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.