LATERAL FLARE INTERNAL COLLAR (LFIC)— 510(k) K971900

Name: FDA 510(k) clearance K971900
Creator: U.S. Food and Drug Administration
Published: 1997-12-18

Substantially Equivalent

Pro-Lfic, LLC

FDA 510(k) clearance K971900 for LATERAL FLARE INTERNAL COLLAR (LFIC), Substantially Equivalent on 1997-12-18. Applicant: Pro-Lfic, LLC. Device class: 2.

Clearance details

Applicant: Pro-Lfic, LLC
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1997-05-23
Decision date: 1997-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwich, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.