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510(k) K111443

X12 STERILE REFLECTIVE MARKER SPHERE by Pinsco Inc. Dba B & L Engineering — Product Code OLO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2011
Date Received
May 24, 2011
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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