ORTHOBLEND POWERED BONE MILL— 510(k) K860356

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K860356 for ORTHOBLEND POWERED BONE MILL, Substantially Equivalent on 1986-07-08. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code LYS
Advisory panel: Orthopedic
Date received: 1986-01-30
Decision date: 1986-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code LYS

product code LYS

Malfunction: 1,152
Total: 1,152

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.