510(k) K020298
K020298 is an FDA 510(k) premarket notification submitted by Plus Orthopedics for the device "GALILEO CAS/NAV TKR SYSTEM". The FDA issued a decision of Substantially Equivalent on May 20, 2002. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Plus Orthopedics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2002
- Date Received
- January 28, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurological Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- NE
- Submission Type