ACROMED ADS BONE NAIL— 510(k) K862552

Name: FDA 510(k) clearance K862552
Creator: U.S. Food and Drug Administration
Published: 1986-09-02

Substantially Equivalent

Buckman Co., Inc.

FDA 510(k) clearance K862552 for ACROMED ADS BONE NAIL, Substantially Equivalent on 1986-09-02. Applicant: Buckman Co., Inc.. Device class: 2.

Clearance details

Applicant: Buckman Co., Inc.
Product code: Code KTW
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1986-07-03
Decision date: 1986-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, CA, US

Download summary PDF View on FDA.gov ↗

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K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)2012-09-20

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K964252 — ORTHOCHUCK1997-05-27
K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM1997-01-16
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Adverse events under product code KTW

product code KTW

Injury: 220
Total: 220

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.