AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION— 510(k) K953720
Substantially Equivalent for Some IndicationsAesculap, Inc.
FDA 510(k) clearance K953720 for AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION, Substantially Equivalent for Some Indications on 1995-11-02. Applicant: Aesculap, Inc..
Clearance details
- Applicant
- Aesculap, Inc.
- Product code
- Code KWQ
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- South San Francisco, CA, US
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.