SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS— 510(k) K033411
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K033411 for SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS, Substantially Equivalent on 2003-11-26. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Product code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Paoli, PA, US
Recent devices under product code KTT
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Adverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.