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510(k) K133974

VARIAX DISTAL RADIUS PLATING SYSTEM by Stryker Leibinger GmbH — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2014
Date Received
December 26, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Stryker Leibinger GmbH

  • 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)
  • 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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