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510(k) K102957

CUTTING EDGE SPINE INTERBODY FUSION DEVICE by Cutting Edge Spine, LLC — Product Code MAX

K102957 is an FDA 510(k) premarket notification submitted by Cutting Edge Spine, LLC for the device "CUTTING EDGE SPINE INTERBODY FUSION DEVICE". The FDA issued a decision of Substantially Equivalent on April 28, 2011. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Cutting Edge Spine, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2011
Date Received
October 5, 2010
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 Cutting Edge Spine, LLC

  • K250605 — EVOL® ha – Hyper C Cervical Interbody Fusion System (March 12, 2025)
  • K230689 — T-FIX™ 3DSI Joint Fusion System (April 5, 2023)
  • K214123 — T-FIX® 3DSI Joint Fusion System (June 24, 2022)
  • K200991 — EVOL Spinal Interbody System (May 13, 2020)
  • K200552 — EVOS Lumbar Interbody System (April 2, 2020)
  • K192497 — EVOL ha - D Lateral Interbody Fusion System (January 6, 2020)
  • K190025 — EVOL® -SI Joint Fusion System (August 12, 2019)
  • K180674 — EVOL® ha-C Cervical Interbody Fusion System (June 25, 2018)
  • K180891 — EVOL Spinal Interbody System, EVOS Lumbar Interbody System (May 4, 2018)
  • K150321 — EVOS Lumbar Interbody System (July 13, 2015)

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