K231809
- 510(k) number
- K231809
- Device name
- Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
- Applicant
- Ulrich Medical USA TX · US
- Product code
- PML — Bone Cement, Posterior Screw Augmentation
- Decision date
- 2023-10-20
- Date received
- 2023-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K231809.pdf
Official FDA record: K231809
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.