Medline UNITE REFLEX Dynamic Discs— 510(k) K211612
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K211612 for Medline UNITE REFLEX Dynamic Discs, Substantially Equivalent on 2021-12-10. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code HTN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northfiled, IL, US
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Adverse events under product code HTN
product code HTN- Injury
- 310
- Malfunction
- 639
- Total
- 949
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.