510(k) K121765

SCULPTOR ROBOTIC GUIDANCE ARM (RGA) by Stanmore Implants Worldwide , Ltd. — Product Code OLO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 11, 2013
Date Received: June 15, 2012
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.

Other clearances by Stanmore Implants Worldwide , Ltd.

K140898 — PATIENT SPECIFIC DISTAL FEMORAL (January 20, 2015)
K133152 — JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (January 22, 2014)
K121056 — METS MODULAR PROXIMAL FEMUR (September 20, 2012)
K121055 — METS MODULAR TOTAL FEMUR (September 19, 2012)
K121029 — METS MODULAR DISTAL FEMUR (September 19, 2012)
K120992 — METS SMILES TOTAL KNEE REPLACEMENT (September 5, 2012)
K092138 — JTS EXTENDEABLE IMPLANT (March 22, 2011)

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