SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM— 510(k) K953778
Substantially Equivalent for Some IndicationsAdvanced Spine Fixation Systems, Inc.
FDA 510(k) clearance K953778 for SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM, Substantially Equivalent for Some Indications on 1995-11-06. Applicant: Advanced Spine Fixation Systems, Inc..
Clearance details
- Applicant
- Advanced Spine Fixation Systems, Inc.
- Product code
- Code MNH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Adverse events under product code MNH
product code MNH- Injury
- 978
- Malfunction
- 793
- Total
- 1,771
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.