SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE— 510(k) K926453
Substantially Equivalent for Some IndicationsSynthes (Usa)
FDA 510(k) clearance K926453 for SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE, Substantially Equivalent for Some Indications on 1993-10-12. Applicant: Synthes (Usa). Device class: 2.
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Paoli, PA, US
Recent devices under product code KWQ
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Adverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
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.