K241387
- 510(k) number
- K241387
- Device name
- CoLink NeoFuse MIS Plating System (see attached parts list)
- Applicant
- In2bones USA TN · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2024-08-13
- Date received
- 2024-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K241387.pdf
Official FDA record: K241387
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.