Kisar Stratford SI Screw System— 510(k) K220274
Substantially EquivalentAnjali Investments L.L.C
FDA 510(k) clearance K220274 for Kisar Stratford SI Screw System, Substantially Equivalent on 2023-04-24. Applicant: Anjali Investments L.L.C. Device class: 2.
Clearance details
- Applicant
- Anjali Investments L.L.C
- Product code
- Code OUR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lutherville, MD, US
Recent devices under product code OUR
view allAdverse events under product code OUR
product code OUR- Death
- 3
- Injury
- 347
- Total
- 350
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.