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510(k) K242826

ProLift Wedge Expandable Spacer System by Life Spine, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2024
Date Received
September 18, 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 Life Spine, Inc.

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  • K250373 — ProLift Expandable Spacer System (April 9, 2025)
  • K243668 — ProLift Pivot Expandable Spacer System (January 23, 2025)
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  • K232611 — TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System (November 30, 2023)
  • K231704 — Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System (October 19, 2023)
  • K223430 — ProLift Micro Expandable Spacer System (May 4, 2023)

Other clearances for product code MAX

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  • K250773 — Luna® Ti Interbody Fusion System (February 4, 2026)
  • K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spac (January 23, 2026)
  • K253266 — Titanium Interbody System (January 8, 2026)
  • K253577 — IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (December 19, 2025)
  • K252610 — ZSFab Lumbar Interbody System (November 25, 2025)
  • K252351 — UniSpace® TPLIF Cage (October 28, 2025)
  • K253377 — Expandable Titanium PLIF/TLIF System (October 24, 2025)
  • K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion C (September 18, 2025)