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510(k) K091381

IBEX SPINAL SYSTEM by Ebi, L.P. — Product Code MAX

K091381 is an FDA 510(k) premarket notification submitted by Ebi, L.P. for the device "IBEX SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on August 7, 2009. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Ebi, L.P. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2009
Date Received
May 11, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Ebi, L.P.

  • K100438 — POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM (June 23, 2010)
  • K100220 — POLARIS SPINAL SYSTEM (May 17, 2010)
  • K093880 — PEANUT GROWTH CONTROL PLATING SYSTEM (April 16, 2010)
  • K092574 — ESL SPINAL SYSTEM (February 4, 2010)
  • K093057 — BIOMET VISION FOOTRING SYSTEM (December 1, 2009)
  • K092336 — C-THRU SPINAL SYSTEM (October 15, 2009)
  • K090203 — 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS (July 30, 2009)
  • K090523 — POLARIS SPINAL SYSTEM (July 1, 2009)
  • K082406 — EXPANDABLE PEEK-OPTIMA IMPLANT (January 14, 2009)
  • K082187 — BIOMET ANTERIOR LUMBAR PLATE (November 13, 2008)

Other clearances for product code MAX

  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources