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510(k) K230876

RI.KNEE Adjustable Tibia Cut Guide by Enztec Limited — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2023
Date Received
March 30, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

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