ORTHOBLEND POWERED BONE MILL— 510(k) K860356

Name: FDA 510(k) clearance K860356
Creator: U.S. Food and Drug Administration
Published: 1986-07-08

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K860356 for ORTHOBLEND POWERED BONE MILL, Substantially Equivalent on 1986-07-08. Applicant: Zimmer, Inc.. Device class: 1.

Clearance details

Applicant: Zimmer, Inc.
Product code: Product code LYS
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1986-01-30
Decision date: 1986-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYS

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K883183 — TRACER BONE MILL1988-10-12
K861164 — OSTEOMILL BONE GRINDER1986-05-02
K860016 — AESCULAP BONE MILL1986-03-19

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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.