510(k) DEN220015
- Device
- Orthobond Mariner Pedicle Screw System
- Applicant
- Orthobond Coporation
- 510(k) number
- DEN220015
- Product code
- QZY
- Decision
- Unknown (DENG)
- Decision date
- 2024-04-05
- Date received
- 2022-02-28
- Regulation
- 888.3071
- Classification name
- Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- David Nichols
- Address
- 1 Deerpark Dr. Suite A Monmouth NJ US 08852 08852
Source Documents
510(k) summary PDF not indicated by FDA