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510(k) K193174

Keos Lumbar IBFD by Keos — Product Code MAX

K193174 is an FDA 510(k) premarket notification submitted by Keos for the device "Keos Lumbar IBFD". The FDA issued a decision of Substantially Equivalent on Dec 16, 2019. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Keos has 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 16, 2019
Date Received
Nov 18, 2019
Clearance Type
Special
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
510(k)

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

Other clearances by Keos

  • K212450 — Keos Anterior Cervical Interbody Fusion Device System (Jun 6, 2022)
  • K163386 — Keos Lumbar IBFD (Apr 10, 2017)
  • K160631 — Keos Lumbar IBFD (Jul 15, 2016)

Other clearances for product code MAX

  • K261049 — SCALA® TL (Aug 20, 2026)
  • K261430 — TruLift Expandable System (Jul 28, 2026)
  • K253011 — Catalyft PL Expandable Interbody System (Jul 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (Jul 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… (Jul 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (Jun 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)

FDA data resources