K161809
Substantially EquivalentShurFit CpTi-HA ACIF Interbody Fusion System
- Applicant
- Precision Spine, Inc.
- Product code
- ODP
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pear, MS, US
Adverse events under product code ODP
product code ODP- Injury
- 310
- Total
- 310
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.