ACROMED BONE SCREW TAP SLEEVES— 510(k) K873067

Name: FDA 510(k) clearance K873067
Creator: U.S. Food and Drug Administration
Published: 1987-09-02

Substantially Equivalent

Buckman Co., Inc.

FDA 510(k) clearance K873067 for ACROMED BONE SCREW TAP SLEEVES, Substantially Equivalent on 1987-09-02. Applicant: Buckman Co., Inc.. Device class: 1.

Clearance details

Applicant: Buckman Co., Inc.
Product code: Code HWX
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1987-08-05
Decision date: 1987-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWX

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K840735 — FEMORAL CEMENT REMOVAL INSTRUMENT1984-05-14

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K950099 — SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM1997-01-16
K960451 — WEBB-MORLEY SPINE SYSTEM1996-04-18

Adverse events under product code HWX

product code HWX

Malfunction: 559
Total: 559

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.