Medline UNITE Ancillary Foot Recon Plating System
FDA 510(k) clearance K234031 · decided 2024-01-18
Clearance details
- K-number
- K234031
- Device name
- Medline UNITE Ancillary Foot Recon Plating System
- Applicant
- Medline Industires, LP
- Decision
- Substantially Equivalent
- Date received
- 2023-12-20
- Decision date
- 2024-01-18
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Northfiled, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.