Response Ortho Metaphyseal Hinge Fixator System— 510(k) K241769
Substantially EquivalentResponse Ortho Solutions, LLC
FDA 510(k) clearance K241769 for Response Ortho Metaphyseal Hinge Fixator System, Substantially Equivalent on 2024-09-18. Applicant: Response Ortho Solutions, LLC. Device class: 2.
Clearance details
- Applicant
- Response Ortho Solutions, LLC
- Product code
- Code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boynton Beach, FL, US
Recent devices under product code KTT
view allMore clearances from Response Ortho Solutions, LLC
view allAdverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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.