Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement +1 more— 510(k) K231809
Substantially EquivalentUlrich Medical USA
FDA 510(k) clearance K231809 for Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement +1 more, Substantially Equivalent on 2023-10-20. Applicant: Ulrich Medical USA. Device class: 2.
Clearance details
- Device name as filed
- 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
- Product code
- Code PML
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
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More clearances from Ulrich Medical USA
view allAdverse events under product code PML
product code PML- Death
- 8
- Total
- 8
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.