Orthobond Mariner Pedicle Screw System
FDA 510(k) clearance DEN220015 · decided 2024-04-05
Clearance details
- K-number
- DEN220015
- Device name
- Orthobond Mariner Pedicle Screw System
- Applicant
- Orthobond Coporation
- Decision
- Unknown
- Date received
- 2022-02-28
- Decision date
- 2024-04-05
- Days to decision
- 767 days
- Clearance type
- Direct
- Product code
- QZY
- Device class
- 2
- Regulation number
- 888.3071
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Monmouth, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.