510(k) K152764
K152764 is an FDA 510(k) premarket notification submitted by Blue Ortho for the device "EXACTECH GPS". The FDA issued a decision of Substantially Equivalent on Jul 13, 2016. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Blue Ortho has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 13, 2016
- Date Received
- Sep 24, 2015
- 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
- 510(k)