510(k) K121765
K121765 is an FDA 510(k) premarket notification submitted by Stanmore Implants Worldwide , Ltd. for the device "SCULPTOR ROBOTIC GUIDANCE ARM (RGA)". The FDA issued a decision of Substantially Equivalent on Jan 11, 2013. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Stanmore Implants Worldwide , Ltd. has 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 11, 2013
- Date Received
- Jun 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
- 510(k)
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.