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510(k) K022579

STRYKER NAVIGATION SYSTEM-KNEE MODULE by Stryker Leibinger — Product Code HAW

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

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  • K040022 — STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM (March 12, 2004)
  • K023449 — NON-INVASIVE PATIENT FIXATION SYSTEM (January 13, 2003)
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  • K012380 — MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL F (December 3, 2001)
  • K000594 — LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE (December 8, 2000)
  • K000348 — COLORADO MICRODISSECTION NEEDLE (May 3, 2000)

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