LINK CERAMIC HEADS 12/14 X 32MM— 510(k) K931571

Name: FDA 510(k) clearance K931571
Creator: U.S. Food and Drug Administration
Published: 1994-04-19

Substantially Equivalent for Some Indications

Link America, Inc.

FDA 510(k) clearance K931571 for LINK CERAMIC HEADS 12/14 X 32MM, Substantially Equivalent for Some Indications on 1994-04-19. Applicant: Link America, Inc.. Device class: 2.

Clearance details

Applicant: Link America, Inc.
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 1993-03-30
Decision date: 1994-04-19
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Denville, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.

Clearance details

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