ADVANCED TURBO DRIVE SYSTEM— 510(k) K050519
Substantially EquivalentLinvatec Corp.
FDA 510(k) clearance K050519 for ADVANCED TURBO DRIVE SYSTEM, Substantially Equivalent on 2005-05-17. Applicant: Linvatec Corp.. Device class: 1.
Clearance details
- Applicant
- Linvatec Corp.
- Product code
- Code GEY
- Device class
- Class 1
- Regulation
- 21 CFR 878.4820
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Largo, FL, US
Recent devices under product code GEY
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- K083281 — EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-
Adverse events under product code GEY
product code GEY- Malfunction
- 7,488
- Total
- 7,488
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K050519
K-number listed on FDA's recall record- Z-0916-2013 — D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
- Z-0917-2013 — D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050519.
Data sourced from openFDA. This site is unofficial and independent of the FDA.