Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti— 510(k) K150643
Substantially EquivalentCentinel Spine, Inc.
FDA 510(k) clearance K150643 for Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti, Substantially Equivalent on 2015-06-08. Applicant: Centinel Spine, Inc..
Clearance details
- Applicant
- Centinel Spine, Inc.
- Product code
- Code OVD
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Adverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
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.