ROWE SHOULDER INSTR. FOR BANKHART REPAIR— 510(k) K820344

Substantially Equivalent

New England Surgical Instrument Corp.

FDA 510(k) clearance K820344 for ROWE SHOULDER INSTR. FOR BANKHART REPAIR, Substantially Equivalent on 1982-03-08. Applicant: New England Surgical Instrument Corp..

Clearance details

Applicant: New England Surgical Instrument Corp.
Product code: Code HTD
Advisory panel: General, Plastic Surgery
Date received: 1982-02-08
Decision date: 1982-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.