Medline UNITE® REFLEX® Hybrid Nitinol Implant System— 510(k) K243888
Substantially EquivalentMedline Industries, LP
FDA 510(k) clearance K243888 for Medline UNITE® REFLEX® Hybrid Nitinol Implant System, Substantially Equivalent on 2025-04-11. Applicant: Medline Industries, LP. Device class: 2.
Clearance details
- Applicant
- Medline Industries, LP
- Product code
- Code JDR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northfield, IL, US
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Adverse events under product code JDR
product code JDR- Injury
- 726
- Malfunction
- 663
- Other
- 1
- Total
- 1,390
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.