ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM— 510(k) K875021

Name: FDA 510(k) clearance K875021
Creator: U.S. Food and Drug Administration
Published: 1987-12-30

Substantially Equivalent

Buckman Co., Inc.

FDA 510(k) clearance K875021 for ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM, Substantially Equivalent on 1987-12-30. Applicant: Buckman Co., Inc.. Device class: 2.

Clearance details

Applicant: Buckman Co., Inc.
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1987-12-04
Decision date: 1987-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.