ECTRA II LIGAMENT RELEASE SYSTEM— 510(k) K954627

Substantially Equivalent for Some Indications

Smith & Nephew Dyonics, Inc.

FDA 510(k) clearance K954627 for ECTRA II LIGAMENT RELEASE SYSTEM, Substantially Equivalent for Some Indications on 1995-12-18. Applicant: Smith & Nephew Dyonics, Inc..

Clearance details

Applicant: Smith & Nephew Dyonics, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1995-10-06
Decision date: 1995-12-18
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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.