APEX TUBING SET— 510(k) K954440
Substantially EquivalentLinvatec Corp.
FDA 510(k) clearance K954440 for APEX TUBING SET, Substantially Equivalent on 1995-11-02. Applicant: Linvatec Corp.. Device class: 2.
Clearance details
- Applicant
- Linvatec Corp.
- Product code
- Code HRX
- Device class
- Class 2
- Regulation
- 21 CFR 888.1100
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Largo, FL, 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, 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 K954440
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954440.
Data sourced from openFDA. This site is unofficial and independent of the FDA.