AESCULAP BONE MILL— 510(k) K860016

Name: FDA 510(k) clearance K860016
Creator: U.S. Food and Drug Administration
Published: 1986-03-19

Substantially Equivalent

Aesculap Instruments Corp.

FDA 510(k) clearance K860016 for AESCULAP BONE MILL, Substantially Equivalent on 1986-03-19. Applicant: Aesculap Instruments Corp.. Device class: 1.

Clearance details

Applicant: Aesculap Instruments Corp.
Product code: Code LYS
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1986-01-03
Decision date: 1986-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlingame, CA, US

Download summary PDF View on FDA.gov ↗

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K883183 — TRACER BONE MILL1988-10-12
K860356 — ORTHOBLEND POWERED BONE MILL1986-07-08
K861164 — OSTEOMILL BONE GRINDER1986-05-02

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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.