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510(k) K012380

MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY by Stryker Leibinger — Product Code HAW

K012380 is an FDA 510(k) premarket notification submitted by Stryker Leibinger for the device "MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY". The FDA issued a decision of Substantially Equivalent on December 3, 2001. 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
December 3, 2001
Date Received
July 26, 2001
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

Other clearances by Stryker Leibinger

  • K133974 — VARIAX DISTAL RADIUS PLATING SYSTEM (March 24, 2014)
  • K052871 — STRYKER CUSTOM TI IMPLANT (December 16, 2005)
  • K043250 — STRYKER PATIENT SPECIFIC POLYMER IMPLANT (April 15, 2005)
  • K041651 — STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM (September 30, 2004)
  • K040022 — STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM (March 12, 2004)
  • K022579 — STRYKER NAVIGATION SYSTEM-KNEE MODULE (June 2, 2003)
  • K023449 — NON-INVASIVE PATIENT FIXATION SYSTEM (January 13, 2003)
  • K013775 — TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM (January 8, 2002)
  • K000594 — LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE (December 8, 2000)
  • K000348 — COLORADO MICRODISSECTION NEEDLE (May 3, 2000)

Other clearances for product code HAW

  • K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot) (September 10, 2026)
  • K261932 — Leksell® Vantage Stereotactic System (August 5, 2026)
  • K253663 — Zeta Navigation System (May 1, 2026)
  • K253379 — Stealth AXiS Cranial clinical application (March 26, 2026)
  • K231897 — NeuroAlign software (October 21, 2025)
  • K251317 — SOLOPASS 2.0 System (September 5, 2025)
  • K250893 — Ball Joint Guide Array (66295) (September 4, 2025)
  • K250505 — EZ-FIDUCIALS (July 9, 2025)
  • K242575 — Stereotaxic Guiding Surgical Devices, NaoTrac S (May 23, 2025)
  • K241327 — Navient Image Guide Navigation System (955-NC-NC), Cranial (February 5, 2025)

FDA data resources