Atlas FDA

UC-PLUS SOLUTION UNICONDYLAR KNEE

FDA 510(k) clearance K032052 · decided 2003-07-25

Clearance details

K-number
K032052
Device name
UC-PLUS SOLUTION UNICONDYLAR KNEE
Applicant
Plus Orthopedics
Decision
Substantially Equivalent
Date received
2003-07-02
Decision date
2003-07-25
Days to decision
23 days
Clearance type
Special
Product code
HRY
Device class
2
Regulation number
888.3530
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Round Rock, TX, US
Third-party review
No
Expedited review
No

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SIGNATURE PLANNER / SIGNATURE GUIDES (K110415)Materialise NV2011-05-16
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Recalls involving this device

RecordFirmDate
UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 2 recall (Z-0192-2007)Plus Orthopedics USA2006-11-16