Home / 510(k) Clearances / K992367

510(k) K992367

EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS by Electro-Biology, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1999
Date Received
July 15, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Electro-Biology, Inc.

  • K992333 — EBI OMEGA 21 SYSTEM (October 8, 1999)
  • K991941 — EBI XFIX DFS RAIL SYSTEM (August 19, 1999)
  • K990303 — EBI OMEGA 21 SYSTEM (April 29, 1999)
  • K991092 — EBI SPINELINK ANTERIOR CERVICAL SPINAL 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)
  • K981483 — EBI DFS JOINT FIXATOR, MODEL 02800 (July 8, 1998)

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