Atlas FDA

CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System

FDA 510(k) clearance K193543 · decided 2020-01-17

Clearance details

K-number
K193543
Device name
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System
Applicant
In2bones USA, LLC
Decision
Substantially Equivalent
Date received
2019-12-20
Decision date
2020-01-17
Days to decision
28 days
Clearance type
Special
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.