K232292
- 510(k) number
- K232292
- Device name
- Peridot-EX Expandable Intervertebral Body Fusion System
- Applicant
- Gbs Commonwealth Co., Ltd. KR
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2023-11-07
- Date received
- 2023-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K232292.pdf
Official FDA record: K232292
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.