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510(k) K113781

PANTHEON SPINAL IBFD SYSTEM by Pantheon Spinal — Product Code MAX

K113781 is an FDA 510(k) premarket notification submitted by Pantheon Spinal for the device "PANTHEON SPINAL IBFD SYSTEM". The FDA issued a decision of Substantially Equivalent on April 26, 2013. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Pantheon Spinal has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2013
Date Received
December 22, 2011
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 Pantheon Spinal

  • K241494 — Pantheon Pedicle Screw and Iliac Bolt Fixation System (July 26, 2024)
  • K203003 — Pantheon IBFD (July 7, 2021)
  • K181548 — Pantheon Spinal Pontus Interbody Fusion Device (December 16, 2019)

Other clearances for product code MAX

  • 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)
  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K253583 — LUX Expandable Lumbar Interbody System (February 23, 2026)
  • K250773 — Luna® Ti Interbody Fusion System (February 4, 2026)

FDA data resources