ChoiceSpine Tiger Shark Cervical Spacer System— 510(k) K201643
Substantially EquivalentChoice Spine, LLC
FDA 510(k) clearance K201643 for ChoiceSpine Tiger Shark Cervical Spacer System, Substantially Equivalent on 2020-12-22. Applicant: Choice Spine, LLC.
Clearance details
- Applicant
- Choice Spine, LLC
- Product code
- Code ODP
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Knoxville, TN, 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.