Home / 510(k) Clearances / K140734

510(k) K140734

NEXTGEN ALTIUS OCT SYSTEM by Ebi, LLC — Product Code KWP

K140734 is an FDA 510(k) premarket notification submitted by Ebi, LLC for the device "NEXTGEN ALTIUS OCT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 15, 2014. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Ebi, LLC has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2014
Date Received
March 24, 2014
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 Ebi, LLC

  • K190837 — Internal Hex Implant System (January 22, 2020)
  • K170031 — Internal Octa Implant System (August 31, 2017)
  • K142426 — EBI External Implant System (March 27, 2015)
  • K140123 — POLARIS SPINAL SYSTEM -TRANSLATION SCREW (April 24, 2014)
  • K113796 — SOLITAIRE-C CERVICAL SPACER SYSTEM (April 26, 2012)
  • K111376 — CONSTRUX EXTERNAL FIXATION DEVICE (August 3, 2011)
  • K073116 — EBI INTERNAL IMPLANT SYSTEM (February 28, 2008)

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