510(k) K022579
K022579 is an FDA 510(k) premarket notification submitted by Stryker Leibinger for the device "STRYKER NAVIGATION SYSTEM-KNEE MODULE". The FDA issued a decision of Substantially Equivalent on June 2, 2003. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Stryker Leibinger has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2003
- Date Received
- August 5, 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