HD LifeSciences Cervical IBFD System— 510(k) K180364
Substantially EquivalentHd Lifesciences, LLC
FDA 510(k) clearance K180364 for HD LifeSciences Cervical IBFD System, Substantially Equivalent on 2018-06-27. Applicant: Hd Lifesciences, LLC.
Clearance details
- Applicant
- Hd Lifesciences, LLC
- Product code
- Code ODP
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stoneham, MA, 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.