510(k) K172849
K172849 is an FDA 510(k) premarket notification submitted by Intellijoint Surgical, Inc. for the device "Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray". The FDA issued a decision of Substantially Equivalent on November 16, 2017. The device falls under product code OLO (Orthopedic Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Intellijoint Surgical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2017
- Date Received
- September 20, 2017
- Clearance Type
- Special
- 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.