DEN220015
- 510(k) number
- DEN220015
- Device name
- Orthobond Mariner Pedicle Screw System
- Applicant
- Orthobond Coporation NJ · US
- Product code
- QZY — Spinal Fusion System With 12-Methacryloyloxydodecyl
- Decision date
- 2024-04-05
- Date received
- 2022-02-28
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Orthopedic
Official FDA record: DEN220015
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.