K231899
- 510(k) number
- K231899
- Device name
- HAtetracell-C Titanium Cervical IBF System
- Applicant
- Innovasis, Inc. UT · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2023-10-17
- Date received
- 2023-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K231899.pdf
Official FDA record: K231899
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.