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510(k) K243934

Stable-L Lumbar Interbody System by Nexus Spine, LLC — Product Code OVD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2025
Date Received
December 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Nexus Spine, LLC

  • K253331 — PressON Spinal Fixation System (October 14, 2025)
  • K241467 — Stable-C Interbody System (July 17, 2024)
  • K233375 — Tranquil-L Interbody System (March 20, 2024)
  • K240416 — Tranquil-C Interbody System (March 12, 2024)
  • K233234 — PressON Spinal Fixation System (October 26, 2023)
  • K231486 — Stable-L Standalone Lumbar Interbody System (October 12, 2023)
  • K232530 — Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (September 18, 2023)
  • K231763 — Stable-C Interbody System (August 21, 2023)
  • K223529 — PressON Spinal Fixation System (May 2, 2023)
  • K223627 — PreView-III™ Anterior Cervical Plate System (February 2, 2023)

Other clearances for product code OVD

  • K253559 — Ventana™ A Anterior Lumbar Interbody System (February 25, 2026)
  • K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
  • K251575 — IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interb (September 3, 2025)
  • K250072 — CONDUIT™ SYNFIX™ Evolution Secured Spacer System (July 10, 2025)
  • K251644 — ProAM ALIF System (June 24, 2025)
  • K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
  • K251459 — OneLIF™ Interbody Fusion System (June 12, 2025)
  • K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
  • K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)
  • K243802 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lu (March 17, 2025)