SMILJANIC BONE REPOSITIONING FORCEPS— 510(k) K871535

Substantially Equivalent

Link America, Inc.

FDA 510(k) clearance K871535 for SMILJANIC BONE REPOSITIONING FORCEPS, Substantially Equivalent on 1987-05-14. Applicant: Link America, Inc..

Clearance details

Applicant: Link America, Inc.
Product code: Code HTD
Advisory panel: General, Plastic Surgery
Date received: 1987-04-20
Decision date: 1987-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Hanavor, NJ, US

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Adverse events under product code HTD

product code HTD

Malfunction: 892
Total: 892

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.