MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15— 510(k) K990845
Substantially EquivalentAdvanced Spine Fixation Systems, Inc.
FDA 510(k) clearance K990845 for MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15, Substantially Equivalent on 1999-04-13. Applicant: Advanced Spine Fixation Systems, Inc..
Clearance details
- Applicant
- Advanced Spine Fixation Systems, Inc.
- Product code
- Code KWP
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Adverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
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.