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510(k) K241413

sagAlign Lumbar Cage System (Various PNs) by Acuity Surgical Devices, LLC — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2024
Date Received
May 17, 2024
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 Acuity Surgical Devices, LLC

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  • K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
  • K230639 — Align Cervical Interbody Fusion System (December 1, 2023)
  • K222561 — Align (September 23, 2022)
  • K221535 — Align Lumbar Interbody Fusion System (July 22, 2022)
  • K201671 — A-Link Z (May 4, 2021)

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  • K252351 — UniSpace® TPLIF Cage (October 28, 2025)
  • K253377 — Expandable Titanium PLIF/TLIF System (October 24, 2025)
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