KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM— 510(k) K940537

Substantially Equivalent

Kirschner Medical Corp.

FDA 510(k) clearance K940537 for KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM, Substantially Equivalent on 1995-08-29. Applicant: Kirschner Medical Corp..

Clearance details

Applicant: Kirschner Medical Corp.
Product code: Code KWT
Advisory panel: Orthopedic
Date received: 1994-02-07
Decision date: 1995-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fair Lawn, NJ, US

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Adverse events under product code KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.