FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES— 510(k) K973614

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K973614 for FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES, Substantially Equivalent on 1997-12-18. Applicant: Encore Orthopedics, Inc..

Clearance details

Applicant: Encore Orthopedics, Inc.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1997-09-23
Decision date: 1997-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.