TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER— 510(k) K946313

Substantially Equivalent

Smith and Nephew Donjoy, Inc.

FDA 510(k) clearance K946313 for TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER, Substantially Equivalent on 1995-03-17. Applicant: Smith and Nephew Donjoy, Inc..

Clearance details

Applicant: Smith and Nephew Donjoy, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1994-12-28
Decision date: 1995-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carsbad, CA, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.