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510(k) K261159

Exceed® Biplanar Expandable Interbody System by Spine Wave, Inc. — Product Code MAX

K261159 is an FDA 510(k) premarket notification submitted by Spine Wave, Inc. for the device "Exceed® Biplanar Expandable Interbody System". The FDA issued a decision of Substantially Equivalent on May 29, 2026. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Spine Wave, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2026
Date Received
April 8, 2026
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 Spine Wave, Inc.

  • K260286 — Dynamo™ Spinal Cement; Salvo® Spine System (June 15, 2026)
  • K243816 — Testa TP Pivoting Spacer System (June 27, 2025)
  • K251131 — Annex® 2 Adjacent Level System (June 6, 2025)
  • K243514 — Salvo® Robotic Navigation Instruments (April 3, 2025)
  • K240685 — Salvo® Spine System (May 6, 2024)
  • K231275 — Exceed™ Biplanar Expandable Interbody System (July 25, 2023)
  • K222362 — Salvo® Spine System (August 29, 2022)
  • K202476 — Salvo® Spine System (November 5, 2020)
  • K192526 — Spine Wave Navigated Instruments (October 10, 2019)
  • K191045 — Salvo™ Spine System (July 10, 2019)

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)
  • 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)

FDA data resources