LTJ Screws and Washer— 510(k) K210268

Name: FDA 510(k) clearance K210268
Creator: U.S. Food and Drug Administration
Published: 2021-02-26

Substantially Equivalent

Azurmeds, Inc.

FDA 510(k) clearance K210268 for LTJ Screws and Washer, Substantially Equivalent on 2021-02-26. Applicant: Azurmeds, Inc.. Device class: 2.

Clearance details

Applicant: Azurmeds, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2021-02-01
Decision date: 2021-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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K260106 — OsteoCoil GT Active Compression System2026-08-24
K262344 — Large Compression Screws2026-08-12
K253858 — GFS - Sterile Screws and Top Hat2026-08-05
K262075 — Lapidus Screw Kit2026-07-22

More clearances from Azurmeds, Inc.

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K200987 — LTJ Screws and Washer2020-09-22

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.