K240568
- 510(k) number
- K240568
- Device name
- DuraPro Oscillating System
- Applicant
- Globus Medical, Inc. PA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-04-29
- Date received
- 2024-02-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K240568.pdf
Official FDA record: K240568
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.