Home / 510(k) Clearances / K953406

510(k) K953406

EBI X FIX DYNAFIX SYSTEM (DFS) by Electro-Biology, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1995
Date Received
July 20, 1995
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)

Other clearances for product code KTT

  • K253291 — Excelsior System (January 20, 2026)
  • K253202 — Hoffmann LRF System (December 19, 2025)
  • K253613 — Monkey Rings External Ring Fixation System (December 19, 2025)
  • K252555 — Medusa Orthopedics Boa External Fixation System (November 25, 2025)
  • K252625 — The Response Ortho Smart Fixator - Hexapod System (November 20, 2025)
  • K252106 — External Fixation Mini Rail System (September 30, 2025)
  • K251862 — External Fixation Bone Distractor (August 11, 2025)
  • K250472 — SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (August 8, 2025)
  • K251128 — Extremity Medical External Fixation System (May 7, 2025)
  • K243798 — Orthex External Fixation System (March 7, 2025)