K241738
- 510(k) number
- K241738
- Device name
- PYXIS 3D Titanium Cervical Cage system
- Applicant
- GS Medical Co., Ltd. KR
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2024-08-20
- Date received
- 2024-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241738.pdf
Official FDA record: K241738
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.