Home / 510(k) Clearances / K961433

510(k) K961433

EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS by Electro-Biology, Inc. — Product Code KTT

Clearance Details

Decision
SN ()
Decision Date
June 28, 1996
Date Received
April 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Electro-Biology, Inc.

  • K992333 — EBI OMEGA 21 SYSTEM (October 8, 1999)
  • K992367 — EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS (September 23, 1999)
  • K991941 — EBI XFIX DFS RAIL SYSTEM (August 19, 1999)
  • K991092 — EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM (April 29, 1999)
  • K990303 — EBI OMEGA 21 SYSTEM (April 29, 1999)
  • K990459 — EBI VUECATH ENDOSCOPIC SYSTEN (April 23, 1999)
  • K990999 — MODIFICATION OF: EBI SPINELINK SYSTEM (April 14, 1999)
  • K984027 — EBI SPINELINK SYSTEM (January 19, 1999)
  • K982484 — EBI VUECATH ENDOSCOPIC SPINAL SYSTEM (October 8, 1998)
  • K982908 — MODIFICATION TO EBI SPINELINK SYSTEM (August 28, 1998)

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