LACTOSORB TRAUMA PLATING SYSTEM— 510(k) K955729

Substantially Equivalent for Some Indications

Poly-Medics,Inc.

FDA 510(k) clearance K955729 for LACTOSORB TRAUMA PLATING SYSTEM, Substantially Equivalent for Some Indications on 1996-02-14. Applicant: Poly-Medics,Inc..

Clearance details

Applicant: Poly-Medics,Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 1995-12-18
Decision date: 1996-02-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.