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510(k) K240113

CORIOGRAPH Knee Pre-Op Plan by Smith & Nephew, Inc. — Product Code PBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2024
Date Received
January 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopaedic Surgical Planning And Instrument Guides
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.

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Other clearances for product code PBF

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