TRACER BONE MILL— 510(k) K883183

Name: FDA 510(k) clearance K883183
Creator: U.S. Food and Drug Administration
Published: 1988-10-12

Substantially Equivalent

De Medica Mfg., Inc.

FDA 510(k) clearance K883183 for TRACER BONE MILL, Substantially Equivalent on 1988-10-12. Applicant: De Medica Mfg., Inc.. Device class: 1.

Clearance details

Applicant: De Medica Mfg., Inc.
Product code: Code LYS
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1988-07-28
Decision date: 1988-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Paula, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYS

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K860356 — ORTHOBLEND POWERED BONE MILL1986-07-08
K861164 — OSTEOMILL BONE GRINDER1986-05-02
K860016 — AESCULAP BONE MILL1986-03-19

More clearances from De Medica Mfg., Inc.

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K884406 — TRACER HIP PINNING SYSTEM1988-11-28
K884407 — TRACER SKELETAL TRACTION PINS1988-11-28

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.