HEALICOIL SUTURE ANCHOR WITH REGENESORB— 510(k) K123393

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K123393 for HEALICOIL SUTURE ANCHOR WITH REGENESORB, Substantially Equivalent on 2013-04-11. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2012-11-02
Decision date: 2013-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.