K230946
- 510(k) number
- K230946
- Device name
- Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L
- Applicant
- Trax Surgical MA · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2023-09-15
- Date received
- 2023-04-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K230946.pdf
Official FDA record: K230946
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.