SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET— 510(k) K120390

Substantially Equivalent

Solana Surgical, LLC

FDA 510(k) clearance K120390 for SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET, Substantially Equivalent on 2012-04-10. Applicant: Solana Surgical, LLC.

Clearance details

Applicant: Solana Surgical, LLC
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2012-02-07
Decision date: 2012-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.