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510(k) K982908

MODIFICATION TO EBI SPINELINK SYSTEM by Electro-Biology, Inc. — Product Code KWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1998
Date Received
August 18, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

Other clearances by Electro-Biology, Inc.

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  • 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)
  • K981483 — EBI DFS JOINT FIXATOR, MODEL 02800 (July 8, 1998)

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