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510(k) K052871

STRYKER CUSTOM TI IMPLANT by Stryker Leibinger — Product Code GXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2005
Date Received
October 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Device Class
Class II
Regulation Number
882.5330
Review Panel
NE
Submission Type

Other clearances by Stryker Leibinger

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  • 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)
  • K012380 — MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL F (December 3, 2001)
  • K000594 — LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE (December 8, 2000)
  • K000349 — MOTORIZED MICRO MULTILEAF COLLIMATOR (May 3, 2000)

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