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510(k) K990303

EBI OMEGA 21 SYSTEM by Electro-Biology, Inc. — Product Code KWP

K990303 is an FDA 510(k) premarket notification submitted by Electro-Biology, Inc. for the device "EBI OMEGA 21 SYSTEM". The FDA issued a decision of Substantially Equivalent on April 29, 1999. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Electro-Biology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1999
Date Received
February 1, 1999
Clearance Type
Traditional
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.

  • 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)
  • 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)

Other clearances for product code KWP

  • K143278 — LnK Posterior Cervical Fixation System (July 29, 2015)
  • K150753 — OASYS System (June 9, 2015)
  • K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System (June 4, 2015)
  • K142867 — Reliance Posterior Cervical-Thoracic System (April 29, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (April 28, 2015)
  • K142253 — SOLSTICE OCT System (April 23, 2015)
  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
  • K142741 — OASYS System (January 15, 2015)
  • K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System (December 22, 2014)

FDA data resources