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510(k) K990999

MODIFICATION OF: EBI SPINELINK SYSTEM by Electro-Biology, Inc. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1999
Date Received
March 25, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
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)
  • 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)
  • 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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