K242442
- 510(k) number
- K242442
- Device name
- Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
- Applicant
- Innovate Orthopaedics, Ltd. GB
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2025-01-31
- Date received
- 2024-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K242442.pdf
Official FDA record: K242442
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.